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.
Reported: August 8, 2018 Initiated: July 26, 2018 #D-1022-2018
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.
Details
- Recalling Firm
- H J Harkins Company Inc dba Pharma Pac
- Units Affected
- 540 tablets
- Distribution
- Product was distributed to a physician's office.
- Location
- Grover Beach, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by H J Harkins Company Inc dba Pharma Pac. Units affected: 540 tablets.
Why was this product recalled? ▼
Carcinogen impurity detected in API used to manufacture drug product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Moderate. Recall number: D-1022-2018.
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