Multi-event August 2020 FDA Recall Drug by Family Pharmacy Of Statesville

This Multi-event Class II drug recall was voluntarily initiated by Family Pharmacy Of Statesville on August 6, 2020 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in NC only and the recall is currently terminated.

Reported Recall Events

D-0662-2022 TERMINATED D-0667-2022 TERMINATED D-0659-2022 TERMINATED D-0665-2022 TERMINATED D-0656-2022 TERMINATED D-0666-2022 TERMINATED D-0664-2022 TERMINATED D-0660-2022 TERMINATED D-0663-2022 TERMINATED D-0658-2022 TERMINATED D-0657-2022 TERMINATED D-0661-2022 TERMINATED

Recall Number: D-0662-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
3 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# Lot: 07312020@2 BUD: 9/14/2020

Recall Number: D-0667-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
1 bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07312020@5 BUD: 8/14/2020

Recall Number: D-0659-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
1 bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 08022020@1 BUD: 8/17/2020

Recall Number: D-0665-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
1 bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07312020@6 BUD: 8/7/2020

Recall Number: D-0656-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
2 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07212020@4 BUD: 10/19/2020; 07212020@4 BUD: 10/30/2020

Recall Number: D-0666-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
5 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07282020@3 BUD: 8/11/2020

Recall Number: D-0664-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
3 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07212020@1 BUD: 8/4/2020; 07232020@2 BUD: 8/6/2020; 07302020@2 BUD: 8/13/2020

Recall Number: D-0660-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
2 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07212020@ BUD: 9/4/2020

Recall Number: D-0663-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
8 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07212020@3 BUD: 10/19/2020; 07292020@2 BUD: 10/27/2020

Recall Number: D-0658-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
1 bag

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07292020@7 BUD: 8/12/2020

Recall Number: D-0657-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
4 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# : 07272020@2 BUD: 10/25/2020; 07302020@1 BUD: 10/28/2020; 08012020@1 BUD: 10/30/2020

Recall Number: D-0661-2022

Reason for Recall
Lack of Assurance of Sterility
Initiated
08-06-2020
Reported
03-23-2022
Quantity
5 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89773
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.
Family Pharmacy of Statesville
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NC only
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2023
Product Description About Product Description
Full technical description of the product.
Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Batch or Lot Expiration Information

Lot# :07232020@1 BUD: 9/6/2020; 07282020@1 BUD: 9/11/2020; 07282020@2 BUD: 9/11/2020