Multi-event May 2018 FDA Recall Drug by Guardian Pharmacy Services

This Multi-event Class II drug recall was voluntarily initiated by Guardian Pharmacy Services on May 17, 2018 for the product Drug. The FDA reported the reason for recall as lack of sterility assurance.. The product was distributed in Texas and the recall is currently terminated.

Reported Recall Events

D-1070-2018 TERMINATED D-1051-2018 TERMINATED D-1064-2018 TERMINATED D-1067-2018 TERMINATED D-1061-2018 TERMINATED D-1063-2018 TERMINATED D-1062-2018 TERMINATED D-1052-2018 TERMINATED D-1060-2018 TERMINATED D-1066-2018 TERMINATED D-1069-2018 TERMINATED D-1065-2018 TERMINATED D-1072-2018 TERMINATED D-1058-2018 TERMINATED D-1055-2018 TERMINATED D-1059-2018 TERMINATED D-1053-2018 TERMINATED D-1056-2018 TERMINATED D-1054-2018 TERMINATED D-1071-2018 TERMINATED D-1068-2018 TERMINATED D-1073-2018 TERMINATED D-1057-2018 TERMINATED

Recall Number: D-1070-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
100 50-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 59097:42 Use By: 07/23/2018

Recall Number: D-1051-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
20 25-ml CADD

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58440:42 Use By: 05/23/2018; 58624:42 Use By: 06/11/2018; 58962:42 Use By: 07/11/2018

Recall Number: D-1064-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
20 400-ml ON-Q Pump

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 59088:42 Use By: 05/24/2018; 59159:42 Use By: 05/30/2018

Recall Number: D-1067-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
60 20-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58758; 58760; 58756, 59095:42, 59093:42; 59091:42

Recall Number: D-1061-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
60 5-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58611:42 Use By: 06/07/2018; 59099:42 Use By: 07/24/2018; 58786:42 Use By: 06/24/2018

Recall Number: D-1063-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
300 2-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58854:42 Use By: 06/28/2018

Recall Number: D-1062-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
95 1-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 59185:42 Use By: 07/30/2018; 58471:42 Use By: 05/27/2018; 58745:42 Use By: 06/10/2018

Recall Number: D-1052-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
4900 100-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58495:42 Use By: 05/22/2018; 58703/58733 Use By: 06/10/2018; 58852:42 Use By: 06/22/2018; 59006:42 Use By: 07/10/2018

Recall Number: D-1060-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
1000 100-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58212:42 Use By: 06/01/2018

Recall Number: D-1066-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
3 750-ml ON-Q Pump

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 59103:42 Use By: 05/25/2018

Recall Number: D-1069-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
250 10-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58641:42 Use By: 06/04/2018; 58775:42 Use By: 06/16/2018; 59077:42 Use By: 07/17/2018

Recall Number: D-1065-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
25 550-ml ON-Q Pump

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 59086:42 Use By: 05/24/2018; 59163:42 Use By: 05/30/2018

Recall Number: D-1072-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
250 50-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58618:42 UB, Use By: 06/10/2018

Recall Number: D-1058-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
2 1-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58895:42 Use By: 06/27/2018

Recall Number: D-1055-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
1 1-ml syringe

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58897:42 Use By: 07/04/2018

Recall Number: D-1059-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
442 1-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58895:42 Use By: 06/27/2018; 58856:42 Use By: 06/21/2018

Recall Number: D-1053-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
5000 500-ml bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58555:42, 58567:42, 58563:42, 58547:42, 58565:42, Use By: 05/25/2018

Recall Number: D-1056-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
2400 100-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58436:42 Use By: 05/22/2018; 58653:42 Use By: 06/12/2018; 58773:42, 58766:42, Use By: 06/21/2018; 58766:42 Use By: 06/20/2018

Recall Number: D-1054-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
2600 100 ml bags/vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: a) 58572:42 Use By: 05/29/2018 b) 58768:42 Use By: 06/20/2018

Recall Number: D-1071-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
2000 100-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018

Recall Number: D-1068-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
100 50-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58653:42 Use By: 06/12/2018; 58773/58766 Use By: 06/21/2018; 58766:42 Use By: 06/20/2018

Recall Number: D-1073-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
40 10-ml vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lots: 58913:42 Use By: 06/05/2018

Recall Number: D-1057-2018

Reason for Recall
Lack of sterility assurance.
Initiated
05-17-2018
Reported
08-15-2018
Quantity
100 2-ml syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80118
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.
Guardian Pharmacy Services
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.
Texas
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-25-2020
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Batch or Lot Expiration Information

Lot# Lot: 58811:93 Use By: 06/18/2018