Zydus Recalls Ethacrynate Sodium Injection Vials Due to cGMP Deviations
Zydus Pharmaceuticals is recalling 2,207 vials of Ethacrynate Sodium for Injection due to current Good Manufacturing Practice (cGMP) deviations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall, which typically involves risks of temporary or medically reversible adverse health consequences. The source does not report any specific injuries or illnesses, placing it in the 'High' severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zydus Pharmaceuticals USA Inc. has voluntarily recalled 2,207 vials of Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial. The product is distributed nationwide in the United States and is manufactured by Cadila Healthcare Limited in Ahmedabad, India.
The recall was initiated on January 31, 2020, due to current Good Manufacturing Practice (cGMP) deviations. The affected lots are M804062 (Expiration 01/2020), M804063 (Expiration 02/2020), and M804064 (Expiration 02/2020). The FDA classified this recall as Class II, which indicates a situation that might cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. The recall status is currently terminated, having been closed on October 26, 2021.
The recalled product
- 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.
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 2,207
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #s: M804062
- Exp. 01/2020
- M804063
- M804064
- Exp. 02/2020
Distribution
Distributed nationwide across the United States.
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