FDA recall D-1114-2018

Hetero Labs Limited Unit V · Class II · drug

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

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution

Nationwide

Key facts

Status: Completed
Initiation date: 2018-08-08
Report date: 2018-08-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Jadcherla Mandal, Mahaboob Nagar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1114-2018