Recalls / Class III
Class IIID-1058-2014
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
- Affected lot / code info
- Lot V120131
Why it was recalled
Failed Dissolution Specification; 8 hr stability timepoint
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 14,357 bottles
- Distribution pattern
- US nationwide (including PR)
Timeline
- Recall initiated
- 2013-11-04
- FDA classified
- 2014-02-03
- Posted by FDA
- 2014-02-12
- Terminated
- 2015-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1058-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.