Recalls / Class II
Class IID-1340-2019
Product
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
- Brand name
- Estradiol Vaginal Inserts
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Vaginal
- NDC
- 68462-711
- FDA application
- ANDA210264
- Affected lot / code info
- Lot#: 20180516, Exp 4/30/2020
Why it was recalled
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 31,656 boxes
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-06-03
- FDA classified
- 2019-06-11
- Posted by FDA
- 2019-06-19
- Terminated
- 2022-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1340-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.