November 2013 FDA Recall Drug by Greenstone Llc
D-1059-2014 - Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval

This Class III drug recall was voluntarily initiated by Greenstone Llc on November 4, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1059-2014

Reason for Recall
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Initiated
11-04-2013
Reported
02-12-2014
Quantity
22,529 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66814
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Greenstone Llc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide (including PR)
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-24-2015
Product Description About Product Description
Full technical description of the product.
Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

Batch or Lot Expiration Information

Lot# lot V112000, EXP Jun 2016