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.
Reported: March 28, 2018 Initiated: March 19, 2018 #D-0620-2018
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 640,486 vaginal inserts
- Distribution
- Distributed within the United States and Puerto Rico.
- Location
- North Wales, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teva Pharmaceuticals USA. Units affected: 640,486 vaginal inserts.
Why was this product recalled? ▼
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 28, 2018. Severity: Moderate. Recall number: D-0620-2018.
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