March 2018 FDA Recall Estradiol by Teva Pharmaceuticals Usa
D-0620-2018 - Defective Container

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on March 19, 2018 for the product Estradiol. The FDA reported the reason for recall as defective container. The product was distributed in Distributed within the United States and Puerto Rico. and the recall is currently terminated.

Recall Number: D-0620-2018

Reason for Recall
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Initiated
03-19-2018
Reported
03-28-2018
Quantity
640,486 vaginal inserts

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79542
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.
Distributed within the United States and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-15-2019
Product Description About Product Description
Full technical description of the product.
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wales, PA 19454.

Batch or Lot Expiration Information

Lot# : a) 33812545A, 33812546A, 33812774A, Exp. 12/2018; 33812775A, Exp. 01/2019; 33812776A, 33812777A, Exp. 05/2019; 33813786A, 33813868A, Exp. 7/2019; 33813974A, 33814058A, Exp. 09/2019; 33814113A, Exp. 01/2019; b) 33812547A, 33813361A,33813676A, Exp. 1/2019

Affected Packages Involved in this Recall

0093-3223-08 Estradiol
0093-3223-19 Estradiol
0093-3223-97 Estradiol