Reported Jun 19, 2019 · Terminated

Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only,…

Glenmark Pharmaceuticals Inc., USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009

Is this the product you have?

  • Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only
  • Manufactured byGlenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India
  • Manufactured forGlenmark Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC 68462-711-71
Lot codes and dates
    • Lot#: 20180516
    • Exp 4/30/2020
Amount recalled
31,656 boxes

Where it was sold

  • Nationwide

Why it was recalled

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 2, 2022 · Data as of Sep 19, 6:37 PM UTC

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