Zolpidem Tartrate Tablets Recalled for Potential Unit Dose Mispackaging
American Health Packaging is recalling Zolpidem Tartrate 5 mg tablets due to a packaging error that may result in blisters containing more than one tablet.
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 hazard involves a packaging error that could lead to accidental overdose, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary recalls without reported serious injury.
Plain-English summary
American Health Packaging is recalling Zolpidem Tartrate Tablets 5 mg (NDC 68084-225-01) due to a random undetected packaging issue. The defect could cause a small number of individual unit dose blisters to be packed with more than one tablet.
The recall involves 48.230 carton units distributed nationwide. The affected lots include 114215, 114216, 114217, 120087, 120295, 121573, 123572, 123983, and 130071, with expiration dates ranging from July 2013 to February 2015. The product is manufactured for Wockhardt USA LLC. by Wockhardt Limited.
This is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed and stop using the product if it matches the recall criteria.
The recalled product
- Product
- Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
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 (14)
- Lot #: 114215
- Exp 7/13
- 114216
- 114217
- 120087
- Exp 9/13
- 120295
- 121573
- Exp 6/14
- 123572
- Exp 9/14
- 123983
- 130071
- Exp 2/15
Distribution
Distributed nationwide across the United States.
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