Home / Recalls / H J Harkins Company Inc dba Pharma Pac / D-1022-2018

D-1022-2018 Class II Terminated

Recalled by H J Harkins Company Inc dba Pharma Pac — Grover Beach, CA

Recall Details

Product Type
Drugs
Report Date
August 8, 2018
Initiation Date
July 26, 2018
Termination Date
January 18, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
540 tablets

Product Description

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.

Reason for Recall

Carcinogen impurity detected in API used to manufacture drug product.

Distribution Pattern

Product was distributed to a physician's office.

Code Information

Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09

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