Why it was recalled
Carcinogen impurity detected in API used to manufacture drug product.
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.
Lot numbers, UPCs & expiration codes
Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
Where it was sold
Product was distributed to a physician's office.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1022-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 26, 2018
- FDA report date
- Aug 8, 2018
- Quantity
- 540 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
Original FDA data
Every field from FDA enforcement report D-1022-2018, exactly as published.
Show all FDA fields
- City
- Grover Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 80674
- Address
- 1400 W Grand Ave Ste F
- Code information
- Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
- Postal code
- 93433-4221
- Report date
- Aug 8, 2018
- Product type
- Drugs
- Recall number
- D-1022-2018
- Classification
- Class II
- Recalling firm
- H J Harkins Company Inc dba Pharma Pac
- Product quantity
- 540 tablets
- Termination date
- Jan 18, 2019
- Reason for recall
- Carcinogen impurity detected in API used to manufacture drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed to a physician's office.
- Recall initiation date
- Jul 26, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2018