Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure
Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities. The hazard is a quality control failure (dissolution) without reported adverse health consequences, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Actavis Inc is recalling 167,152 bottles of Glipizide 2.5 mg Extended-Release tablets, 30-count, Rx Only. The product is manufactured by Patheon Pharmaceuticals Inc in Cincinnati, OH, and carries NDC 00591-0900-30. The affected lots are # 3132593, 3132594, 3134420, 3134421, and 3134422, all with an expiration date of 02/17.
The recall was initiated because the tablets exceeded dissolution specification rates for the 10-hour testing point. This means the medication may not release the active ingredient as intended over time.
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recall criteria, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 167,152
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 (6)
- Lot # 3132593
- 3132594
- 3134420
- 3134421
- 3134422
- Exp. 02/17
Distribution
Distributed nationwide across the United States.
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