Multi-event July 2018 FDA Recall Valsartan by Bryant Ranch Prepack Inc.

This Multi-event Class II drug recall was voluntarily initiated by Bryant Ranch Prepack Inc. on July 27, 2018 for the product Valsartan. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed in HI, IN, and FL. and the recall is currently terminated.

Reported Recall Events

D-1028-2018 TERMINATED D-1027-2018 TERMINATED D-1029-2018 TERMINATED

Recall Number: D-1028-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-27-2018
Reported
08-08-2018
Quantity
990 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80634
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.
Bryant Ranch Prepack 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.
Product was distributed in HI, IN, and FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Batch or Lot Expiration Information

Lot# 114319; Exp. 10/18
Lot# 109004; Exp. 12/18

Recall Number: D-1027-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-27-2018
Reported
08-08-2018
Quantity
690 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80634
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.
Bryant Ranch Prepack 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.
Product was distributed in HI, IN, and FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Batch or Lot Expiration Information

Lot# 111158; Exp. 02/19

Recall Number: D-1029-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-27-2018
Reported
08-08-2018
Quantity
90 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80634
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.
Bryant Ranch Prepack 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.
Product was distributed in HI, IN, and FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2021
Product Description About Product Description
Full technical description of the product.
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Batch or Lot Expiration Information

Lot# 120879; Exp 10/19

Affected Packages Involved in this Recall

71335-0567-1 Valsartan
71335-0567-2 Valsartan
71335-0567-3 Valsartan
71335-0567-4 Valsartan