Recalls / Class III
Class IIID-1059-2014
Product
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
- Affected lot / code info
- lot V112000, EXP Jun 2016
Why it was recalled
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Recalling firm
- Firm
- Greenstone Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Route 206 North, Peapack, New Jersey 07977
Distribution
- Quantity
- 22,529 bottles
- Distribution pattern
- US Nationwide (including PR)
Timeline
- Recall initiated
- 2013-11-04
- FDA classified
- 2014-02-03
- Posted by FDA
- 2014-02-12
- Terminated
- 2015-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1059-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.