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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mylan Pharmaceuticals Inc.
Reason for Recall:
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot #: ZCMH12031, ZCMH12032, ZCMH12033, ZCMH12034, Exp 02/14

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-137-2013

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