D-1047-2019 Class II Terminated
FDA drug recall D-1047-2019 was initiated by American Health Packaging on March 6, 2019 and is designated Class II. Reason for recall: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient. The recall status is terminated (terminated September 9, 2020). Affected quantity: 3337 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 27, 2019
- Initiation Date
- March 6, 2019
- Termination Date
- September 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3337 cartons
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)
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot 179791, Mar 2020