Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot # GKK1373, Exp 09/13
Why it was recalled
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
- Firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1150 Elijah McCoy Dr, N/A, Detroit, Michigan 48202-3344
Distribution
- Quantity
- 2,264 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-11-05
- FDA classified
- 2012-12-06
- Posted by FDA
- 2012-12-12
- Terminated
- 2013-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-089-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.