February 2017 FDA Recall Drug by Remedyrepack Inc.
D-0482-2017 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on February 7, 2017 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Product was distributed to a sold customer in FL. and the recall is currently terminated.

Recall Number: D-0482-2017

Reason for Recall
Failed Dissolution Specifications
Initiated
02-07-2017
Reported
03-01-2017
Quantity
630 pills (21 bottles x 30 pills per HDPE bottle)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76457
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
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.
Product was distributed to a sold customer in FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-05-2017
Product Description About Product Description
Full technical description of the product.
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02

Batch or Lot Expiration Information

Lot# B0129373-021916; Exp. 10/17 00591-0900-30 Original NDC 52125-0764-02 RemedyRepack NDC