Camber Pharmaceuticals recalled over manufacturing violations
- Recall date
- August 8, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals…
- Recall number
- D-1113-2018
- FDA classification
- Class II
- Brand / firm
- Hetero Labs Limited Unit V
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307
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