Recalls / Class II
Class IID-1022-2018
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.
- Affected lot / code info
- Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
Why it was recalled
Carcinogen impurity detected in API used to manufacture drug product.
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, N/A, Grover Beach, California 93433-4221
Distribution
- Quantity
- 540 tablets
- Distribution pattern
- Product was distributed to a physician's office.
Timeline
- Recall initiated
- 2018-07-26
- FDA classified
- 2018-08-01
- Posted by FDA
- 2018-08-08
- Terminated
- 2019-01-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1022-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.