Class II
Terminated
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)
- Company
- American Health Packaging
- Recall Initiated
- March 6, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1047-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3337 cartons
- Firm Location
- Columbus, OH, United States
Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot 179791, Mar 2020
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