traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Ph...
FDA Recall #D-089-2013 — Class II — November 5, 2012
Product Description
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.
Recalling Firm
Caraco Pharmaceutical Laboratories, Ltd. — Detroit, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,264 bottles
Distribution
Nationwide
Code Information
Lot # GKK1373, Exp 09/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated