Valsartan Tablets USP 160 mg recalled over manufacturing violations
- Recall date
- March 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- American Health Packaging recalls Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: Ameri…
- Recall number
- D-1047-2019
- FDA classification
- Class II
- Brand / firm
- American Health Packaging
- Sold / distributed
- Nationwide USA and Puerto Rico
Why it was recalled
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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)
Get recall alerts
Free email alert whenever American Health Packaging has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: American Health Packaging