Drug product
Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
D-1022-2018
Product summary
- Event
- Event 80674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 540 tablets
- Official record key
drug-enforcement:D-1022-2018
Official wording
Reason: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
Distribution pattern: Product was distributed to a physician's office.
Derived failure modes
-
Unknown
Carcinogen impurity detected in API used to manufacture drug product.