Actavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
Actavis Inc is recalling specific lots of Glipizide extended-release tablets because they failed to meet dissolution specifications at the 10-hour testing point.
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, which typically involves a situation where use of, or exposure to, the product may cause temporary or medically reversible health consequences. The specific defect is a dissolution failure, which is a quality control issue rather than a contamination or mislabeling of a common allergen.
Plain-English summary
Actavis Inc is voluntarily recalling specific lots of Glipizide extended-release tablets, 2.5mg, 30-count bottles. The recall involves 499,320 units distributed nationwide in the United States. The affected product is identified by NDC 0591-0900-30 and UPC 3-0591090030-4.
The recall was initiated because the tablets failed to meet dissolution specifications. Specifically, the dissolution rate was observed to be out of specification at the 10-hour testing point. This defect may affect the release of the medication from the tablet.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. Affected lots include 3134201, 3134202, 3134319, 3135246, 3135247, 3136781, 3136782, 3136903, 3136904, 3138250, 3138968, and 3140000. Patients should contact their healthcare provider for guidance on alternative treatment options if they have been prescribed the affected product.
The recalled product
- Product
- Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 499,320
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 (18)
- Lot #: 3134201
- 3134202
- Exp. 06/30/17
- 3134319
- Exp. 05/31/17
- 3135246
- Exp. 07/31/17
- 3135247
- 3136781
- Exp. 08/31/17
- 3136782
- Exp. 09/30/17
- 3136903
- 3136904
- Exp.10/31/17
- 3138250
- 3138968
- 3140000
Distribution
Distributed nationwide across the United States.
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