FDAFDA · Food and drugs·Recall number D-0834-2020
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.
Published February 19, 2020 · Recall initiated: January 31, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Distributor
- Nationwide in the U.S.
- Lot
- Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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