PlainRecalls
FDA Drug Low Class III Terminated

Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

Reported: February 12, 2014 Initiated: November 4, 2013 #D-1059-2014

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

Details

Recalling Firm
Greenstone Llc
Units Affected
22,529 bottles
Distribution
US Nationwide (including PR)
Location
Peapack, NJ

Frequently Asked Questions

What product was recalled?
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2. Recalled by Greenstone Llc. Units affected: 22,529 bottles.
Why was this product recalled?
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Which agency issued this recall?
This recall was issued by the FDA Drug on February 12, 2014. Severity: Low. Recall number: D-1059-2014.