Mylan Recalls Carvedilol Tablets for Weight and Thickness Failures
Mylan Pharmaceuticals is recalling 11,580 bottles of Carvedilol 12.5 mg tablets because they failed specifications for weight and thickness.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to physical specification failures (weight and thickness) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 11,580 bottles of Carvedilol Tablets, USP, 12.5 mg. The recall involves 500-count bottles with NDC 0378-3633-05 and UPC 3 0378-3633-05 3. The affected lots are ZCMH12031, ZCMH12032, ZCMH12033, and ZCMH12034, all with an expiration date of 02/14.
The recall was initiated because the product exceeds specifications for tablet weight and tablet thickness. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled tablets and contact their pharmacist or Mylan Pharmaceuticals for a replacement or refund.
The recalled product
- Product
- 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.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 11,580
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #: ZCMH12031
- ZCMH12032
- ZCMH12033
- ZCMH12034
- Exp 02/14
Distribution
Distributed nationwide across the United States.
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