Home / Recalls / Zydus Pharmaceuticals USA Inc / D-0834-2020

D-0834-2020 Class II Terminated

Recalled by Zydus Pharmaceuticals USA Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
February 19, 2020
Initiation Date
January 31, 2020
Termination Date
October 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2207 Vials

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.

Reason for Recall

cGMP Deviations

Distribution Pattern

Nationwide in the U.S.

Code Information

Lot #s: M804062, Exp. 01/2020; M804063, M804064, Exp. 02/2020

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  • D-1450-2019 Class II — MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cad (May 6, 2019)
  • D-1446-2019 Class II — Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur (May 6, 2019)
  • D-1440-2019 Class II — ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Hea (May 6, 2019)
  • D-1445-2019 Class II — Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufac (May 6, 2019)