Multi-event December 2019 FDA Recall Drug by Assurance Infusion

This Multi-event Class II drug recall was voluntarily initiated by Assurance Infusion on December 20, 2019 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0666-2020 TERMINATED D-0738-2020 TERMINATED D-0675-2020 TERMINATED D-0676-2020 TERMINATED D-0689-2020 TERMINATED D-0743-2020 TERMINATED D-0696-2020 TERMINATED D-0711-2020 TERMINATED D-0692-2020 TERMINATED D-0691-2020 TERMINATED D-0776-2020 TERMINATED D-0754-2020 TERMINATED D-0730-2020 TERMINATED D-0662-2020 TERMINATED D-0712-2020 TERMINATED D-0773-2020 TERMINATED D-0667-2020 TERMINATED D-0678-2020 TERMINATED D-0750-2020 TERMINATED D-0732-2020 TERMINATED D-0701-2020 TERMINATED D-0747-2020 TERMINATED D-0725-2020 TERMINATED D-0763-2020 TERMINATED D-0769-2020 TERMINATED D-0779-2020 TERMINATED D-0772-2020 TERMINATED D-0736-2020 TERMINATED D-0668-2020 TERMINATED D-0699-2020 TERMINATED D-0759-2020 TERMINATED D-0722-2020 TERMINATED D-0720-2020 TERMINATED D-0718-2020 TERMINATED D-0715-2020 TERMINATED D-0753-2020 TERMINATED D-0728-2020 TERMINATED D-0716-2020 TERMINATED D-0765-2020 TERMINATED D-0688-2020 TERMINATED D-0778-2020 TERMINATED D-0704-2020 TERMINATED D-0723-2020 TERMINATED D-0758-2020 TERMINATED D-0755-2020 TERMINATED D-0710-2020 TERMINATED D-0756-2020 TERMINATED D-0764-2020 TERMINATED D-0681-2020 TERMINATED D-0686-2020 TERMINATED D-0683-2020 TERMINATED D-0724-2020 TERMINATED D-0670-2020 TERMINATED D-0719-2020 TERMINATED D-0741-2020 TERMINATED D-0748-2020 TERMINATED D-0757-2020 TERMINATED D-0745-2020 TERMINATED D-0698-2020 TERMINATED D-0740-2020 TERMINATED D-0702-2020 TERMINATED D-0761-2020 TERMINATED D-0731-2020 TERMINATED D-0739-2020 TERMINATED D-0706-2020 TERMINATED D-0682-2020 TERMINATED D-0742-2020 TERMINATED D-0729-2020 TERMINATED D-0705-2020 TERMINATED D-0694-2020 TERMINATED D-0774-2020 TERMINATED D-0714-2020 TERMINATED D-0762-2020 TERMINATED D-0721-2020 TERMINATED D-0693-2020 TERMINATED D-0697-2020 TERMINATED D-0672-2020 TERMINATED D-0717-2020 TERMINATED D-0768-2020 TERMINATED D-0749-2020 TERMINATED D-0770-2020 TERMINATED D-0671-2020 TERMINATED D-0674-2020 TERMINATED D-0664-2020 TERMINATED D-0673-2020 TERMINATED D-0690-2020 TERMINATED D-0669-2020 TERMINATED D-0695-2020 TERMINATED D-0766-2020 TERMINATED D-0713-2020 TERMINATED D-0663-2020 TERMINATED D-0735-2020 TERMINATED D-0777-2020 TERMINATED D-0709-2020 TERMINATED D-0707-2020 TERMINATED D-0685-2020 TERMINATED D-0684-2020 TERMINATED D-0752-2020 TERMINATED D-0760-2020 TERMINATED D-0700-2020 TERMINATED D-0737-2020 TERMINATED D-0679-2020 TERMINATED D-0733-2020 TERMINATED D-0708-2020 TERMINATED D-0665-2020 TERMINATED D-0703-2020 TERMINATED D-0771-2020 TERMINATED D-0746-2020 TERMINATED D-0680-2020 TERMINATED D-0775-2020 TERMINATED D-0687-2020 TERMINATED D-0677-2020 TERMINATED D-0726-2020 TERMINATED D-0767-2020 TERMINATED D-0734-2020 TERMINATED D-0751-2020 TERMINATED D-0727-2020 TERMINATED D-0744-2020 TERMINATED

Recall Number: D-0666-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@20 Exp. 12/20/2019

Recall Number: D-0738-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@12 Exp. 12/20/2019

Recall Number: D-0675-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@2 Exp. 12/25/2019

Recall Number: D-0676-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@18 Exp. 12/20/2019

Recall Number: D-0689-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@4 Exp. 12/21/2019

Recall Number: D-0743-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
4 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12112019@1 Exp. 12/20/2019; 12112019@6 Exp. 12/20/2019; 12162019@23 Exp. 12/25/2019; 12172019@7 Exp. 12/26/2019

Recall Number: D-0696-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@15 Exp. 12/25/2019

Recall Number: D-0711-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12112019@5 Exp. 12/20/2019

Recall Number: D-0692-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@28 Exp. 12/21/2019

Recall Number: D-0691-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12172019@5 Exp. 12/26/2019

Recall Number: D-0776-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
358 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 08082019@7 Exp. 02/04/2020; 08232019@1 Exp. 02/19/2020; 07262019@12 Exp. 01/22/2020; 07012019@25 Exp. 12/28/2019; 07102019@14 Exp. 01/06/2020; 09202019@4 Exp. 03/18/2020; 10282019@23 Exp. 04/25/2020; 10092019@7 Exp. 03/04/2020; 08292019@11 Exp. 02/25/2020; 10042019@6 Exp. 04/01/2020; 10162019@20 Exp. 04/13/2020; 11062019@24 Exp. 03/04/2020; 12042019@20 Exp. 01/18/2020; 12102019@11 Exp. 01/24/2020; 12162019@36 Exp. 01/30/2020; 11262019@29 Exp. 01/10/2020

Recall Number: D-0754-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@31 Exp. 12/21/2019; 12172019@8 Exp. 12/26/2019

Recall Number: D-0730-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@11 Exp. 12/25/2019

Recall Number: D-0662-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
60 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 09262019@13 Exp. 03/24/2020; 10072019@03/04/2020; 12062019@2 Exp. 06/03/2020; 12172019@12 Exp. 01/31/2020; 08142019@20 Exp. 02/10/2020

Recall Number: D-0712-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12102019@6 Exp. 12/19/2019

Recall Number: D-0773-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1290 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 07082019@29 Exp. 01/04/2020; 06252019@11 Exp. 12/22/2019; 07082019@29 Exp. 01/04/2020; 06252019@6 Exp. 12/22/2019; 07082019@28 Exp. 01/04/2020; 07262019@3 Exp. 01/22/2020; 07102019@13 Exp. 01/06/2020; 07162019@13 Exp. 01/12/2020; 07242019@15 Exp. 01/20/2020; 07162019@12 Exp. 01/12/2020; 08272019@11 Exp. 02/23/2020; 08162019@6 Exp. 02/12/2020; 07312019@14 Exp. 01/27/2020; 07262019@4 Exp. 01/22/2020; 08152019@9 Exp. 02/11/2020; 08162019@6 Exp. 02/12/2020; 08092019@6 Exp. 02/05/2020; 07312019@15 Exp. 01/27/2020; 08092019@5 Exp. 02/05/2020; 08272019@12 Exp. 02/23/2020; 09032019@36 Exp. 03/01/2020; 10012019@19 Exp. 03/30/2020; 09162019@15 Exp. 03/14/2020; 09162019@14 Exp. 03/14/2020; 09032019@35 Exp. 03/01/2020; 09032019@35 Exp. 03/01/2020; 09242019@15 Exp. 03/22/2020; 09112019@5 Exp. 03/09/2020; 10022019@15 Exp. 03/30/2020; 09112019@4 Exp. 03/09/2020; 10162019@16 Exp. 04/13/2020; 10282019@21 Exp. 04/25/2020; 10212019@20 Exp. 03/04/2020; 10162019@15 Exp. 04/13/2020; 10282019@22 Exp. 04/25/2020; 10242019@6 Exp. 03/04/2020; 10232019@25 Exp. 03/04/2020 Exp. 10082019@4 Exp. 04/05/2020; 10082019@5 Exp. 04/05/2020; 11262019@26 Exp. 01/10/2020; 12032019@12 Exp. 01/17/2020; 11262019@25 Exp. 01/10/2020; 10302019@24 Exp. 04/27/2020; 11262019@27 Exp. 01/10/2020; 10302019@23 Exp. 04/27/2020; 12032019@11 Exp. 01/17/2020; 11042019@10 Exp. 03/04/2020; 11042019@10 Exp. 03/04/2020; 11262019@24 Exp. 01/10/2020; 12042019@14 Exp. 01/18/2020; 12042019@15 Exp. 01/18/2020; 12102019@14 Exp. 01/24/2020; 12102019@13 Exp. 01/24/2020

Recall Number: D-0667-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12102019@8 Exp. 12/19/2019

Recall Number: D-0678-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 07302019@15 Exp. 01/29/2020

Recall Number: D-0750-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@9 Exp. 12/20/2019

Recall Number: D-0732-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@14 Exp. 12/21/2019

Recall Number: D-0701-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@11 Exp. 12/21/2019

Recall Number: D-0747-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@9 Exp. 12/22/2019

Recall Number: D-0725-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@15 Exp. 12/21/2019

Recall Number: D-0763-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800

Batch or Lot Expiration Information

Lot# Lot: 07012019@30 Exp. 12/28/2019

Recall Number: D-0769-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@19 Exp. 12/21/2019

Recall Number: D-0779-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
45 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020

Recall Number: D-0772-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
166 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 09122019@9 Exp. 03/10/2020; 09242019@9 Exp. 03/22/2020; 09192019@20 Exp. 03/17/2020; 10032019@8 Exp. 03/31/2020; 10032019@11 Exp. 03/31/2020; 10182019@5 Exp. 04/15/2020; 10242019@7 Exp. 04/21/2020; 10232019@24 Exp. 04/20/2020; 11042019@12 Exp. 05/02/2020; 11212019@3 Exp. 05/19/2020; 11212019@2 Exp. 05/19/2020; 11042019@15 Exp. 05/02/2020

Recall Number: D-0736-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800

Batch or Lot Expiration Information

Lot# Lots: 11272019@31 Exp. 12/31/2019; 12022019@19 Exp. 01/05/2020

Recall Number: D-0668-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12172019@3 Exp. 12/26/2019

Recall Number: D-0699-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@3 Exp. 12/22/2019

Recall Number: D-0759-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@7 Exp. 12/21/2019; 12162019@27 Exp. 12/25/2019

Recall Number: D-0722-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@8 Exp. 12/22/2019

Recall Number: D-0720-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
19 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 08212019@29 Exp. 02/17/2020; 07152019@12 Exp. 01/11/2020; 07082019@26 Exp. 01/04/2020

Recall Number: D-0718-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@5 Exp. 12/21/2019

Recall Number: D-0715-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12162019@6 Exp. 12/25/2019

Recall Number: D-0753-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@30 Exp. 12/25/2019

Recall Number: D-0728-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@18 Exp. 12/21/2019; 12162019@24 Exp. 12/25/2019

Recall Number: D-0716-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@12 Exp. 12/21/2019

Recall Number: D-0765-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 08132019@15 Exp. 02/09/2020

Recall Number: D-0688-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 1MG//ML/HYDROM 7MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@10 Exp. 12/20/2019

Recall Number: D-0778-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
20 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 07032019@12 Exp. 12/30/2019; 08212019@32 Exp. 02/17/2020; 10032019@12 Exp. 03/31/2020

Recall Number: D-0704-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@18 Exp. 12/25/2019

Recall Number: D-0723-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@22 Exp. 12/25/2019

Recall Number: D-0758-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
3 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12112019@24 Exp. 12/20/2019; 12122019@1 Exp. 12/21/2019; 12122019@2 Exp. 12/21/2019

Recall Number: D-0755-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
3 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12102019@7 Exp. 12/19/2019; 12112019@11 Exp. 12/20/2019; 12162019@5 Exp. 12/25/2019

Recall Number: D-0710-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12182019@7 Exp. 12/27/2019

Recall Number: D-0756-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@20 Exp. 12/25/2019

Recall Number: D-0764-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
190 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 07012019@30 Exp. 12/28/2019; 08052019@13 Exp. 02/01/2020; 09252019@15 Exp. 03/23/2020; 10292019@12 Exp. 04/26/2020; 10092019@6 Exp. 03/04/2020; 10162019@12 Exp. 04/13/2020; 12042019@31 Exp. 01/18/2020; 12162019@35 Exp. 01/30/2020; 11262019@37 Exp. 05/24/2020

Recall Number: D-0681-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@8 Exp. 12/20/2019

Recall Number: D-0686-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@20 Exp. 12/21/2019

Recall Number: D-0683-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@6 Exp. 12/21/2019

Recall Number: D-0724-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@21 Exp. 12/25/2019

Recall Number: D-0670-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12102019@2 Exp. 12/19/2019

Recall Number: D-0719-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12172019@13 Exp. 12/26/2019

Recall Number: D-0741-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@9 Exp. 12/21/2019

Recall Number: D-0748-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 07162019@20 Exp. 01/12/2020; 12102019@17 Exp. 06/07/2020; 07162019@20 Exp. 01/12/2020

Recall Number: D-0757-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12132019@6 Exp. 12/22/2019; 12182019@5 Exp. 12/27/2019

Recall Number: D-0745-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12182019@6 Exp. 12/27/2019

Recall Number: D-0698-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@27 Exp. 12/21/2019

Recall Number: D-0740-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@7 Exp. 12/25/2019

Recall Number: D-0702-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12202019@1 Exp. 12/20/2019

Recall Number: D-0761-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@21 Exp. 12/20/2019

Recall Number: D-0731-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@30 Exp. 12/21/2019

Recall Number: D-0739-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@3 Exp. 12/25/2019

Recall Number: D-0706-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12162019@28 Exp. 12/25/2019; 12102019@1 Exp. 12/19/2019

Recall Number: D-0682-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@4 Exp. 12/25/2019

Recall Number: D-0742-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@17 Exp. 12/21/2019

Recall Number: D-0729-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12182019@3 Exp. 12/27/2019

Recall Number: D-0705-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@1 Exp. 12/25/2019

Recall Number: D-0694-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@8 Exp. 12/21/2019

Recall Number: D-0774-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 11042019@28 Exp. 05/02/2020

Recall Number: D-0714-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@21 Exp. 12/21/2019

Recall Number: D-0762-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 10142019@14 Exp. 01/12/2020; 11042019@8 Exp. 02/02/2020

Recall Number: D-0721-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@24 Exp. 12/21/2019

Recall Number: D-0693-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12172019@10 Exp. 12/26/2019

Recall Number: D-0697-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@10 Exp. 12/25/2019

Recall Number: D-0672-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@16 Exp. 12/25/2019

Recall Number: D-0717-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12182019@4 Exp. 12/27/2019

Recall Number: D-0768-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@9 Exp. 12/25/2019

Recall Number: D-0749-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes/1 vial

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 09172019@18 Exp. 03/15/2020

Recall Number: D-0770-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 10242019@7 Exp. 04/21/2020; 10032019@11 Exp. 03/31/2020; 11042019@12 Exp. 05/02/2020; 09242019@9 Exp. 03/22/2020

Recall Number: D-0671-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12172019@6 Exp. 12/26/2019

Recall Number: D-0674-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@27 Exp. 12/20/2019

Recall Number: D-0664-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800

Batch or Lot Expiration Information

Lot# Lot: 12172019@2 Exp. 12/26/2019

Recall Number: D-0673-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12202019@2 Exp. 12/20/2019

Recall Number: D-0690-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12102019@3 Exp. 12/19/2019

Recall Number: D-0669-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@7 Exp. 12/20/2019

Recall Number: D-0695-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12182019@1 Exp. 12/27/2019

Recall Number: D-0766-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
134 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 07222019@10 Exp. 01/18/2020; 06242019@19 Exp. 12/21/2019; 08132019@15 Exp. 02/09/2020; 10292019@22 Exp. 04/26/2020; 11272019@24 Exp. 01/22/2020; 09182019@18 Exp. 03/16/2020

Recall Number: D-0713-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12122019@26 Exp. 12/21/2019

Recall Number: D-0663-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
32 droppers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12092019@33 Exp. 03/08/2020; 11112019@30 Exp. 02/09/2020; 10012019@17 Exp. 12/30/2019; 10162019@18 Exp. 01/14/2020; 10252019@11 Exp. 01/23/2020

Recall Number: D-0735-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12162019@38 Exp. 01/16/2020; 11272019@32 Exp. 12/31/2019

Recall Number: D-0777-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 08302019@4 Exp. 02/26/2020

Recall Number: D-0709-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12172019@4 Exp. 12/26/2019

Recall Number: D-0707-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12102019@4 Exp. 12/19/2019

Recall Number: D-0685-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12182019@2 Exp. 12/27/2019

Recall Number: D-0684-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@5 Exp. 12/22/2019

Recall Number: D-0752-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@19 Exp. 12/20/2019

Recall Number: D-0760-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@19 Exp. 12/25/2019

Recall Number: D-0700-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@23 Exp. 12/21/2019

Recall Number: D-0737-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@4 Exp. 12/20/2019

Recall Number: D-0679-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
28 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 11132019@15 Exp. 02/11/2020; 12112019@25 Exp. 02/13/2020; 11202019@9 Exp. 02/13/2020

Recall Number: D-0733-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@1 Exp. 12/22/2019

Recall Number: D-0708-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12102019@5 Exp. 12/19/2019

Recall Number: D-0665-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@23 Exp. 12/20/2019

Recall Number: D-0703-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12112019@17 Exp. 12/20/2019

Recall Number: D-0771-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
7 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 08212019@17 Exp. 02/17/2020; 10232019@23 Exp. 04/20/2020

Recall Number: D-0746-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12132019@4 Exp. 12/22/2019

Recall Number: D-0680-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@29 Exp. 12/25/2019

Recall Number: D-0775-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
10 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 07082019@31 Exp. 01/04/2020

Recall Number: D-0687-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@25 Exp. 12/21/2019

Recall Number: D-0677-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
15 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 09192019@19 Exp. 03/17/2020; 08162019@5 Exp. 02/12/2020

Recall Number: D-0726-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENT 600MCG/ SUF 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@8 Exp. 12/25/2019

Recall Number: D-0767-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12162019@26 Exp. 12/25/2019

Recall Number: D-0734-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 11252019@27 Exp. 12/29/2019; 11272019@30 Exp. 12/31/2019; 12112019@16 Exp. 01/14/2020; 12062019@7 Exp. 01/09/2020

Recall Number: D-0751-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
4 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@13 Exp. 12/21/2019; 12172019@9 Exp. 12/26/2019; 12122019@10 Exp. 12/21/2019; 12162019@13 Exp. 12/25/2019

Recall Number: D-0727-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
1 syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lot: 12122019@3 Exp. 12/21/2019

Recall Number: D-0744-2020

Reason for Recall
Lack of sterility assurance.
Initiated
12-20-2019
Reported
01-22-2020
Quantity
2 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84546
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Assurance Infusion
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Batch or Lot Expiration Information

Lot# Lots: 12162019@14 Exp. 12/25/2019; 12102019@19 Exp. 12/19/2019