CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled
Zydus Pharmaceuticals USA is recalling Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, distributed nationwide in the US. The recall was initiated on 31 Jan 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0834-2020
- FDA event ID
- 84848
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jan 2020
- FDA classified
- 10 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Jan 2020 | Recall initiated by company | |
| 10 Feb 2020 | Classified by FDA | +10 days |
| 19 Feb 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Anastrozole Tablets, 1 mg recalled by Zydus Pharmaceuticals USAAnastrozole | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |