Drug product
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
D-1059-2014
Product summary
- Firm
- Greenstone Llc
- Event
- Event 66814
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22,529 bottles
- Official record key
drug-enforcement:D-1059-2014
Official wording
Reason: Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Code information: lot V112000, EXP Jun 2016
Distribution pattern: US Nationwide (including PR)
Derived failure modes
-
Potency or specification failure
out of specification