GlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets 2.5 mg (Lot #194141) nationwide because dissolution test results exceeded specification, which may affect the drug's effectiveness.
What this means for you
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: This is an FDA Class II recall for a manufacturing defect (failed dissolution specifications). No reports of illness or injury are stated in the source text, and the hazard is a potential efficacy issue rather than a direct safety threat, placing it within the Moderate category.
Plain-English summary
American Health Packaging is recalling GlipiZIDE Extended-Release Tablets, 2.5 mg, 30-tablet cartons (NDC 68084-295-21, Lot #194141, expiration date 03/31/2022) that were manufactured by Patheon Pharmaceuticals Inc. and distributed by Actavis Pharma, Inc. The recall affects approximately 2,266 cartons distributed nationwide within the USA.
The recall was initiated because dissolution test results were above specification. Dissolution testing measures how quickly and completely a tablet breaks down and releases its active ingredient. When dissolution results exceed specification, the tablet may not deliver the intended dose of medication to the patient's bloodstream as designed.
Patients currently taking this medication should contact their healthcare provider or pharmacist before stopping or replacing their medication. Consumers with unused product should not use it and should consult their pharmacist about proper disposal or return options.
The recalled product
- Product
- GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx only, Manufactured by: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054. Carton NDC#: 68084-295-21
- Manufacturer
- American Health Packaging
- Hazard
- failed-dissolution
- efficacy-defect
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 #: 194141
- Exp. Date 03/31/2022
Distribution
Distributed nationwide across the United States.
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