Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceutical
Recalled August 29, 2018 · FDA recall D-1113-2018 · Hetero Labs Limited Unit V
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
316,380 bottles
Sold at
Nationwide
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
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
Manufacturer(s)
Hetero Labs Limited Unit V
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →