Why it was recalled
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Product description
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Lot numbers, UPCs & expiration codes
Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
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-137-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 16, 2013
- FDA report date
- Feb 6, 2013
- Quantity
- 11,580 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-137-2013, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 64154
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
- Postal code
- 26505-2730
- Report date
- Feb 6, 2013
- Product type
- Drugs
- Recall number
- D-137-2013
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 11,580 bottles
- Termination date
- Dec 5, 2013
- Reason for recall
- Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jan 16, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 28, 2013