February 2022 FDA Recall Drug by Coopersurgical, Inc
D-0643-2022 - Non-sterility

This Class I drug recall was voluntarily initiated by Coopersurgical, Inc on February 4, 2022 for the product Drug. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0643-2022

Reason for Recall
Non-sterility
Initiated
02-04-2022
Reported
02-23-2022
Quantity
48,645 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
CooperSurgical, 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.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-06-2023
Product Description About Product Description
Full technical description of the product.
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01

Batch or Lot Expiration Information

Lot# 517001,Exp 1/2024