Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product description
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Lot numbers, UPCs & expiration codes
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).
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0966-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2018
- FDA report date
- Aug 1, 2018
- Quantity
- 5,464 cartons
- Recall type
- N/A
- Recalling firm
- MAJOR PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-0966-2018, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 80557
- Address
- 17177 N Laurel Park Dr
- Code information
- 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).
- Postal code
- 48152-2693
- Report date
- Aug 1, 2018
- Product type
- Drugs
- Recall number
- D-0966-2018
- Classification
- Class II
- Recalling firm
- MAJOR PHARMACEUTICALS
- Product quantity
- 5,464 cartons
- Termination date
- Oct 2, 2022
- Reason for recall
- CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
- Product description
- Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 18, 2018
- Center classification date
- Jul 20, 2018