Alprazolam Tablets Recalled for Unknown Impurity
The Harvard Drug Group is recalling Alprazolam Tablets, 0.25 mg, due to an out-of-specification result for an unknown impurity.
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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when associated with potential adverse health consequences from impurities.
Plain-English summary
The Harvard Drug Group is voluntarily recalling 3,935 cartons of Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets. The product is identified by NDC 0904-5858-61, Lot 1274C151A, and an expiration date of 10/17. The tablets were manufactured by Watson Pharma Private Limited in India and distributed by Actavis Pharma, Inc., and Major Pharmaceuticals.
The recall was initiated because the product failed impurities/degradation specifications, specifically yielding an out-of-specification result for an unknown impurity. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected lot and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa 403 722 INDIA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; Distributed by: Major Pharmaceuticals, 17177 N. Laure
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,935
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 1274C151A
- Exp 10/17
Distribution
Distributed nationwide across the United States.
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