Recalls / Class II
Class IID-0156-2020
Product
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430.
- Brand name
- Estradiol Vaginal Inserts
- Generic name
- Estradiol
- Active ingredient
- Estradiol
- Route
- Vaginal
- NDC
- 68462-711
- FDA application
- ANDA210264
- Affected lot / code info
- Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020
Why it was recalled
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 216,840 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-10-22
- FDA classified
- 2019-10-28
- Posted by FDA
- 2019-11-06
- Terminated
- 2021-06-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0156-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.