Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed ...
FDA Recall #D-1058-2014 — Class III — November 4, 2013
Product Description
Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66
Reason for Recall
Failed Dissolution Specification; 8 hr stability timepoint
Recalling Firm
Pfizer Inc. — New York, NY
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
14,357 bottles
Distribution
US nationwide (including PR)
Code Information
Lot V120131
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated