Class II · Moderate risk Terminated
glipiZIDE
Reason Failed Dissolution Specifications:
Glipizide XL
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
What was recalled
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
- Recalling firm
- Greenstone Llc
- NDC code
- 59762-5032-2
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1059-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Glipizide recalls
See all
Class II · Moderate risk Terminated
GlipiZIDE Extended-Release Tablets
Reason Failed Dissolution Specifications: results were above specification.
Class II · Moderate risk Terminated
GlipiZIDE Extended-release Tablets
Reason 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 Terminated
Glipizide XL
Reason CGMP Deviations; rejected product was used to manufacture final bulk lot
Class III · Low risk Terminated
Glipizide Extended-Release Tablets
Reason Failed Moisture Limits: out of specification test results for water content obtained during stability testing.
Get an alert if your medication is recalled
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.