Class II
Terminated
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.
This recall has been terminated (originally issued November 6, 2019).
- Recall Initiated
- October 22, 2019
- Posted
- November 6, 2019
- Recall Number
- D-0156-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 216,840 cartons
- Firm Location
- Mahwah, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Distribution
Nationwide in the USA
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
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