FDA-Drug2018-03-28Class II
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.
Teva Pharmaceuticals USA
Hazard
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Sold states
Distributed within the United States and Puerto Rico.
Affected count
640,486 vaginal inserts
Manufactured in
1090 Horsham Rd, N/A, North Wales, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0620-2018Don't want to check this manually?
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