Status
Terminated
Drug Enforcement D-089-2013
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.
Classification
Class II
Report Date
December 12, 2012
Termination Date
July 12, 2013
Product Information
- 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.
- Product quantity
- 2,264 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Address
-
1150 Elijah McCoy Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-089-2013
- Event ID
- 63628
- Recall initiation date
- November 5, 2012
- Center classification date
- December 6, 2012
- Code info
- Lot # GKK1373, Exp 09/13
- More code info
- —