Teva Recalls Acarbose Tablets Due to Incorrect Expiration Date Labeling
Teva Pharmaceuticals USA is recalling 3,275 bottles of Acarbose Tablets, 25 mg, because the product labeling displays an incorrect expiration date of July 2018 instead of the correct date of July 2017.
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 involves a labeling error regarding the expiration date. No illnesses or injuries are reported, and the hazard is related to the potential use of expired medication rather than an immediate physical defect or contamination.
Plain-English summary
Teva Pharmaceuticals USA is recalling 3,275 bottles of Acarbose Tablets, 25 mg, 100-count bottles. The product is prescription-only and was distributed nationwide in the USA. The bottles were manufactured by Arrow Pharm (Malta) Ltd. and distributed by Actavis Pharma, Inc. The specific lot number is 1082710A.
The recall was initiated due to a labeling error. The product labeling incorrectly prints an expiration date of July 2018, whereas the correct expiration date is July 2017. This discrepancy may lead to the use of expired medication.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Affected units
- 3,275
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 #: 1082710A
- Exp 07/18
Distribution
Distributed nationwide across the United States.
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