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

FDA recall notice · announced February 12, 2014 · Pfizer

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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

Notes

Distribution: US nationwide (including PR)
Lot/code information: Lot V120131
Quantity: 14,357 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1058-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.