Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmac
Recalled August 29, 2018 · FDA recall D-1114-2018 · Hetero Labs Limited Unit V
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
394,896 bottles
Sold at
Nationwide
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, 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 31722-746-90 UPC 331722746908
Manufacturer(s)
Hetero Labs Limited Unit V
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →