Mylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures
Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.
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, and the source text does not report any illnesses or injuries. The hazard is a quality control failure (dissolution) without reported adverse health consequences, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottles (NDC 0378-5022-91). The recall affects 24,176 bottles, containing a total of 1,450,560 tablets. The specific lot number is 3065878, with an expiration date of 04/17. The product was distributed nationwide.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases into the body as intended. When a medication fails these specifications, it may not provide the expected therapeutic effect or could release the drug at an unintended rate.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (2)
- Code: 0378-5022-91 Lot: 3065878
- Exp. 04/17
Distribution
Distributed nationwide across the United States.
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