Recalls / Class II
Class IID-0966-2018
Product
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
- Affected lot / code info
- 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).
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- MAJOR PHARMACEUTICALS
- Notification channel
- N/A
- Type
- N/A
- Address
- 17177 N Laurel Park Dr, N/A, Livonia, Michigan 48152-2693
Distribution
- Quantity
- 5,464 cartons
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2018-07-18
- FDA classified
- 2018-07-20
- Posted by FDA
- 2018-08-01
- Terminated
- 2022-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0966-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.