FDAFDA · Food and drugs·Recall number D-1047-2019
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)
Published March 27, 2019 · Recall initiated: March 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot 179791, Mar 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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