FDA recall D-1511-2014

Caraco Pharmaceutical Laboratories, Ltd. · Class II · drug

Product

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.

Reason for recall

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2014-06-26
Report date: 2014-08-13
Termination date: 2015-03-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1511-2014