FDA recall D-1115-2018

Product

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905

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-1115-2018