Recalls / Class II
Class IID-0010-2019
Product
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
- Affected lot / code info
- Lot: T71137 Exp. Feb. 2022
Why it was recalled
CGMP Deviations; rejected product was used to manufacture final bulk lot
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, New York, New York 10017-5703
Distribution
- Quantity
- 7777 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-09-20
- FDA classified
- 2018-10-09
- Posted by FDA
- 2018-10-17
- Terminated
- 2020-05-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0010-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.