Reported Mar 27, 2019 · Terminated
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by:…
American Health Packaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
Valsartan Tablets USP 160 mg100 Tablets (10 x 10) per Unit Dose BlistersRx Only
- Packaged and Distributed byAmerican Health Packaging, Columbus
- Ohio 43217 (Individual Dose NDC
60687-139-11Carton NDC#: 60687-139-01)
- Lot codes and dates
Lot 179791Mar 2020
- Amount recalled
- 3337 cartons
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
This product could cause temporary or reversible health problems — stop using it.
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