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: M804062Exp. 01/2020M804063M804064Exp. 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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