March 2012 FDA Recall Drug by Zydus Pharmaceuticals Usa Inc
D-1428-2012 - Presence of Foreign Substance(s

This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on March 14, 2012 for the product Drug. The FDA reported the reason for recall as presence of foreign substance(s). The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1428-2012

Reason for Recall
Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.
Initiated
03-14-2012
Reported
08-08-2012
Quantity
1176 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62605
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.
Zydus Pharmaceuticals USA 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-17-2013
Product Description About Product Description
Full technical description of the product.
Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10.

Batch or Lot Expiration Information

Lot# : ML9605 Exp. 10/2013