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.
Reported: November 6, 2019 Initiated: October 22, 2019 #D-0156-2020
Product Description
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.
Reason for Recall
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 216,840 cartons
- Distribution
- Nationwide in the USA
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 216,840 cartons.
Why was this product recalled? ▼
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 6, 2019. Severity: Moderate. Recall number: D-0156-2020.
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