Actavis Recalls Alprazolam Tablets Due to Weight Specification Failures
Actavis Elizabeth LLC is recalling 756 bottles of Alprazolam 2 mg tablets because some tablets weighed less than the required specification.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies this as an FDA Class II recall. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when structural defects like weight specification failures are involved.
Plain-English summary
Actavis Elizabeth LLC is voluntarily recalling 756 bottles of Alprazolam Orally Disintegrating Tablets, USP 2 mg. The product is distributed nationwide and is identified by Lot # 59380831 with an expiration date of May 2014. The NDC for the recalled product is 0228-4025-11.
The recall was initiated because the tablets failed to meet specifications, specifically resulting in partial tablet erosion and tablet weights below the required standard in some units. This is an FDA Class II recall, which indicates a situation that might cause temporary or medically reversible adverse health consequences.
Consumers who have this specific lot of Alprazolam should stop using it and contact their pharmacist or healthcare provider for guidance on obtaining a replacement or alternative medication. The recalled product is a prescription-only medication.
The recalled product
- Product
- ALPRAZOLAM (ALPRAZOLAM)
- Brand
- ALPRAZOLAM
- Manufacturer
- Actavis Elizabeth LLC
- Category
- Drug — Prescription Medication
- Affected units
- 756
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 # 59380831
- Exp. May 2014
Distribution
Distributed nationwide across the United States.
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