Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed...
FDA Recall #D-1059-2014 — Class III — November 4, 2013
Product Description
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
Reason for Recall
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Recalling Firm
Greenstone Llc — Peapack, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
22,529 bottles
Distribution
US Nationwide (including PR)
Code Information
lot V112000, EXP Jun 2016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated