FDA-Drug2014-02-12Class III

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

Greenstone Llc
Hazard

Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval

Sold states
US Nationwide (including PR)
Affected count
22,529 bottles
Manufactured in
100 Route 206 North, Peapack, NJ, United States
Products
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1059-2014

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