Multi-event July 2018 FDA Recall Drug by Major Pharmaceuticals
This Multi-event Class II drug recall was initiated by Major Pharmaceuticals on July 18, 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
Recall Number: D-0966-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-18-2018
08-01-2018
5,464 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MAJOR PHARMACEUTICALS
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
N/A
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
10-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Batch or Lot Expiration Information
Lot# Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086.
Lot# T-01270 (Expiry: 7/18).
Lot# T-01466 (Expiry: 7/18).
Lot# T-01500 (Expiry:2/19).
Lot# T-01596 (Expiry: 2/19).
Lot# T-01625 (Expiry: 2/19).
Lot# T-01712 (Expiry: 2/19).
Lot# T-01795 (5/19).
Lot# T-01807 (Expiry: 5/19).
Recall Number: D-0967-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
07-18-2018
08-01-2018
4,556 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
MAJOR PHARMACEUTICALS
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
N/A
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide.
10-02-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
Batch or Lot Expiration Information
Lot# Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087.
Lot# T-01269 (Expiry: 7/18).
Lot# T-01524 (Expiry: 2/19).
Lot# T-01646 (Expiry: 5/19).
Lot# T-01668 (Expiry: 5/19).
Lot# T-01788 (Expiry: 5/19).
