Class II
Terminated
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.
- Recall Initiated
- July 26, 2018
- Posted
- August 8, 2018
- Recall Number
- D-1022-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 540 tablets
- Firm Location
- Grover Beach, CA, United States
Reason for Recall
Carcinogen impurity detected in API used to manufacture drug product.
Distribution
Product was distributed to a physician's office.
Lot / Code Info
Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
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