FDA recall D-089-2013

Product

traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; NDC 57664-377-18.

Reason for recall

Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-11-05

Report date

2012-12-12

Termination date

2013-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Detroit, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-089-2013