D-0010-2019 Class II Terminated
FDA drug recall D-0010-2019 was initiated by Pfizer Inc. on Sep 20, 2018 and is designated Class II. Reason for recall: CGMP Deviations; rejected product was used to manufacture final bulk lot The recall status is terminated (terminated May 8, 2020). Affected quantity: 7777 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 17, 2018
- Initiation Date
- Sep 20, 2018
- Termination Date
- May 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7777 bottles
Product Description
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
Reason for Recall
CGMP Deviations; rejected product was used to manufacture final bulk lot
Distribution Pattern
Nationwide
Code Information
Lot: T71137 Exp. Feb. 2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0010-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026