Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Product description
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Lot numbers, UPCs & expiration codes
Lot 179791, Mar 2020
Where it was sold
Nationwide USA and Puerto Rico
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-1047-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2019
- FDA report date
- Mar 27, 2019
- Quantity
- 3337 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1047-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 82316
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot 179791, Mar 2020
- Postal code
- 43217-1188
- Report date
- Mar 27, 2019
- Product type
- Drugs
- Recall number
- D-1047-2019
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 3337 cartons
- Termination date
- Sep 9, 2020
- Reason for recall
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Mar 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 21, 2019