Why it was recalled
cGMP Deviations
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0834-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 31, 2020
- FDA report date
- Feb 19, 2020
- Quantity
- 2207 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0834-2020, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84848
- Address
- 73 Route 31 N
- Code information
- Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020
- Postal code
- 08534-3601
- Report date
- Feb 19, 2020
- Product type
- Drugs
- Recall number
- D-0834-2020
- Classification
- Class II
- Recalling firm
- Zydus Pharmaceuticals USA Inc
- Product quantity
- 2207 Vials
- Termination date
- Oct 26, 2021
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jan 31, 2020
- Initial firm notification
- Letter
- Center classification date
- Feb 10, 2020