Amerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
Amerisource Health Services is recalling specific lots of Glipizide Extended-Release tablets because they failed to meet dissolution specifications.
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, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The specific defect is a failure in dissolution specifications, which is a quality control issue rather than a direct contamination or acute safety hazard like a structural defect or high-risk pathogen.
Plain-English summary
Amerisource Health Services is recalling 19,393 cartons of Glipizide Extended-Release tablets, 2.5 mg. The affected products are distributed nationwide and include specific lot numbers with expiration dates ranging from August 2017 to October 2017.
The recall was initiated because the tablets exceeded dissolution specification rates for the 10-hour testing point. This indicates that the medication may not release the active ingredient as intended over time.
Consumers and healthcare providers should check their inventory for the specific NDC numbers and lot numbers listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Prescription Medication
- Hazard
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 (5)
- Lot #160133
- 160549 Exp. 08/17 Lot #162006
- Exp. 09/17 Lot #163348A
- 163348B
- Exp. 10/17
Distribution
Distributed nationwide across the United States.
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