Reported Mar 28, 2018 · Terminated
Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: a) 33812545A33812546A33812774AExp. 12/201833812775AExp. 01/201933812776A33812777AExp. 05/201933813786A33813868AExp. 7/201933813974A33814058AExp. 09/201933814113AExp. 01/2019b) 33812547A33813361A33813676AExp. 1/2019
- Amount recalled
- 640,486 vaginal inserts
Where it was sold
Why it was recalled
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
This product could cause temporary or reversible health problems — stop using it.
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