February 2017 FDA Recall Drug by G & W Laboratories, Inc.
D-0501-2017 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by G & W Laboratories, Inc. on February 7, 2017 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in Within United States and the recall is currently terminated.

Recall Number: D-0501-2017

Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and out of trend for known impurity results encountered during stability testing.
Initiated
02-07-2017
Reported
03-08-2017
Quantity
3456 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76430
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.
G & W Laboratories, 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.
Within United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-18-2018
Product Description About Product Description
Full technical description of the product.
Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43

Batch or Lot Expiration Information

Lot# : 017600011, Exp. Jan 2018, 0176000014, Exp. Aug 2018, 017600015, Exp. Sep 2018