D-1059-2014 Class III Terminated
FDA drug recall D-1059-2014 was initiated by Greenstone Llc on November 4, 2013 and is designated Class III. Reason for recall: Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval The recall status is terminated (terminated June 24, 2015). Affected quantity: 22,529 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- November 4, 2013
- Termination Date
- June 24, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,529 bottles
Product Description
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2
Reason for Recall
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Distribution Pattern
US Nationwide (including PR)
Code Information
lot V112000, EXP Jun 2016