Reported Feb 19, 2020 · Terminated

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare…

Zydus Pharmaceuticals USA Inc.

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: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

Is this the product you have?

  • Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only
  • Manufactured byCadila Healthcare Limited, Ahmedabad, India
  • Distributed byZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01
Lot codes and dates
    • Lot #s: M804062
    • Exp. 01/2020
    • M804063
    • M804064
    • Exp. 02/2020
Amount recalled
2207 Vials

Where it was sold

  • Nationwide

Why it was recalled

cGMP Deviations

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 Oct 26, 2021 · Data as of Sep 19, 7:18 PM UTC

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