March 2014 FDA Recall Drug by Teva Pharmaceuticals Usa
D-1354-2014 - Non-sterility

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 21, 2014 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed in NY and KY and the recall is currently terminated.

Recall Number: D-1354-2014

Reason for Recall
Non-sterility: due to a failed sterility test
Initiated
03-21-2014
Reported
06-04-2014
Quantity
47890

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67809
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.
Teva Pharmaceuticals USA
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.
NY and KY
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-14-2014
Product Description About Product Description
Full technical description of the product.
ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY

Batch or Lot Expiration Information

Lot# 508004, exp. 4/2015, NDC 51285-204-01, Single Unit 508004, exp. 4/2015, NDC 51285-204-02, Carton of 5 Units