Class II · Moderate risk
glipiZIDE
Failed Dissolution Specifications:
GlipiZIDE Extended-release tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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
Affected NDCs
68084-0295-21
68084-0395-11
Compare with the code on your package — it is the most precise check available.
Drug: Glipizide Category: Diabetes Medication
- Recalling firm
- Amerisource Health Services
- NDC code
- 68084-295-21
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0520-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Glipizide recalls
See all
Class II · Moderate risk
GlipiZIDE Extended-Release Tablets
Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk
GlipiZIDE Extended-release Tablets
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class II · Moderate risk
Glipizide XL
CGMP Deviations; rejected product was used to manufacture final bulk lot
Class III · Low risk
Glipizide Extended-Release Tablets
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Other recalls by Amerisource Health Services
All 2017 recalls
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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