Estradiol Vaginal Inserts USP 10 mcg recall
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
Why was Estradiol Vaginal Inserts USP 10 mcg recalled?
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 20180516, Exp 4/30/2020
- 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
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Quantity
- 31,656 boxes
- Distribution
- U.S.A. Nationwide
- Recall date
- June 19, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)