D-0620-2018 Class II Terminated
FDA drug recall D-0620-2018 was initiated by Teva Pharmaceuticals USA on Mar 19, 2018 and is designated Class II. Reason for recall: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator. The recall status is terminated (terminated Oct 15, 2019). Affected quantity: 640,486 vaginal inserts.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 28, 2018
- Initiation Date
- Mar 19, 2018
- Termination Date
- Oct 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 640,486 vaginal inserts
Product Description
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.
Reason for Recall
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Distribution Pattern
Distributed within the United States and Puerto Rico.
Code 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0620-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026