Home / Recalls / Greenstone Llc / D-1059-2014

D-1059-2014 Class III Terminated

Recalled by Greenstone Llc — Peapack, NJ

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

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  • D-1361-2014 Class I — Venlafaxine HCl Extended-Release Capsules, 150 mg, 90-count Unit of Use bottles, (March 6, 2014)
  • D-746-2014 Class II — sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distrib (November 5, 2013)
  • D-737-2014 Class II — Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Dis (November 1, 2013)
  • D-010-2014 Class II — Spironolactone tablets, USP 25 mg, Rx only, 500 count bottle, Distributed By: Gr (September 4, 2013)
  • D-011-2014 Class II — Spironolactone tablets, USP 50 mg, Rx only, 100 count bottle, Distributed By: Gr (September 4, 2013)