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Recall Observatory FDA recall evidence

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

November 04, 2013

Class III

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

    reason.potency_specification_failure · v1.0.0

    out of specification