American Health Packaging Recalls Glipizide Extended-Release Tablets for Dissolution Failure
American Health Packaging is recalling 2,203 cartons of Glipizide Extended-Release Tablets, 2.5 mg, due to failed dissolution specifications at time zero.
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 corresponds to a Moderate severity score (2) when no specific injuries or hospitalizations are reported in the source text, and the defect is a minor specification deviation.
Plain-English summary
American Health Packaging is voluntarily recalling 2,203 cartons of Glipizide Extended-Release Tablets, 2.5 mg. The affected product is identified by Lot # 181288 and has an expiration date of 5/31/2020. The NDC for the product is 68084-295-21.
The recall was initiated because the repackaged lot failed dissolution specifications. Specifically, drug release results were slightly above specification at time zero. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The product was distributed nationwide in the USA. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or distributor for credit or replacement.
The recalled product
- Product
- GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
- Manufacturer
- American Health Packaging
- 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 (2)
- Lot # 181288
- EXP 5/31/2020
Distribution
Distributed nationwide across the United States.
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