Recalls / Class II
Class IID-0834-2020
Product
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.
- Affected lot / code info
- Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
Why it was recalled
cGMP Deviations
Recalling firm
- Firm
- Zydus Pharmaceuticals USA Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 2207 Vials
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-01-31
- FDA classified
- 2020-02-10
- Posted by FDA
- 2020-02-19
- Terminated
- 2021-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0834-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.