PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: February 12, 2014 Initiated: November 4, 2013 #D-1058-2014

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

Details

Recalling Firm
Pfizer Inc.
Units Affected
14,357 bottles
Distribution
US nationwide (including PR)
Location
New York, NY

Frequently Asked Questions

What product was recalled?
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. Recalled by Pfizer Inc.. Units affected: 14,357 bottles.
Why was this product recalled?
Failed Dissolution Specification; 8 hr stability timepoint
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2014. Severity: Low. Recall number: D-1058-2014.