Actavis Recalls Alprazolam Extended-Release Tablets for Dissolution Failures
Actavis Elizabeth LLC is recalling 5,148 bottles of Alprazolam Extended-Release Tablets, 3 mg, because the product failed to meet dissolution specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, fitting the criteria for a moderate severity rating involving a potential quality defect without confirmed harm.
Plain-English summary
Actavis Elizabeth LLC is voluntarily recalling 5,148 bottles of Alprazolam Extended-Release Tablets, USP, 3 mg. The recalled product is identified by Lot # 57617531 and has an expiration date of 03/14. The bottles contain 60 tablets each and are labeled for prescription use only.
The recall was initiated because the product did not meet specification requirements for dissolution. This means the tablets may not release the medication in the manner intended by the manufacturer.
The affected product was distributed nationwide. Consumers and healthcare providers who have this specific lot of medication should contact their healthcare provider or pharmacist for guidance on whether to stop using the product and how to obtain a replacement.
The recalled product
- Product
- Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 5,148
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)
- Lot #: 57617531
- Exp 03/14
Distribution
Distributed nationwide across the United States.
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