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.
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.
Lot numbers, UPCs & expiration codes
Lot # GKK1373, Exp 09/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-089-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 5, 2012
- FDA report date
- Dec 12, 2012
- Quantity
- 2,264 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
Original FDA data
Every field from FDA enforcement report D-089-2013, exactly as published.
Show all FDA fields
- City
- Detroit
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 63628
- Address
- 1150 Elijah McCoy Dr
- Code information
- Lot # GKK1373, Exp 09/13
- Postal code
- 48202-3344
- Report date
- Dec 12, 2012
- Product type
- Drugs
- Recall number
- D-089-2013
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories, Ltd.
- Product quantity
- 2,264 bottles
- Termination date
- Jul 12, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2012