Multi-event August 2018 FDA Recall Drug by Avkare Inc.

This Multi-event Class II drug recall was voluntarily initiated by Avkare Inc. on August 14, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1130-2018 TERMINATED D-1132-2018 TERMINATED D-1133-2018 TERMINATED D-1131-2018 TERMINATED

Recall Number: D-1130-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
08-14-2018
Reported
09-05-2018
Quantity
6776 cartons (338,800 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80828
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.
AVKARE Inc.
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.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Batch or Lot Expiration Information

Lot# Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019

Recall Number: D-1132-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
08-14-2018
Reported
09-05-2018
Quantity
818 cartons (40,900 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80828
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.
AVKARE Inc.
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.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Batch or Lot Expiration Information

Lot# Lots: 17717 Exp. 07/2018; 18493 Exp. 01/2019; 19761 Exp. 04/2019

Recall Number: D-1133-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
08-14-2018
Reported
09-05-2018
Quantity
1496 cartons (44,880 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80828
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.
AVKARE Inc.
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.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Batch or Lot Expiration Information

Lot# Lots: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019

Recall Number: D-1131-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
08-14-2018
Reported
09-05-2018
Quantity
728 cartons (36,400 tablets)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80828
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.
AVKARE Inc.
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.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-07-2020
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478

Batch or Lot Expiration Information

Lot# Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019