Home / Recalls / Zydus Pharmaceuticals USA Inc / D-1446-2019

D-1446-2019 Class II Terminated

Recalled by Zydus Pharmaceuticals USA Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
June 26, 2019
Initiation Date
May 6, 2019
Termination Date
September 16, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
168,330 90-count bottles

Product Description

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16

Reason for Recall

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Distribution Pattern

Nationwide in the USA

Code Information

Lots:M713431, M713432, M714172, EXP Sep-19; M714173, Oct-19; M800552, M800553, M800554, M800555 M800556 EXP Dec-19; M811135 M812818 M812819 M812820 M812821 EXP Jun-20, M815777 M815778 M815779 M815780 M815781 EXP Aug-20; M901927 M901929 M901931 M901933 M902089 EXP Jan-21

Other recalls by Zydus Pharmaceuticals USA Inc

  • D-0834-2020 Class II — Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Man (January 31, 2020)
  • D-1452-2019 Class II — Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured (May 6, 2019)
  • D-1450-2019 Class II — MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cad (May 6, 2019)
  • D-1453-2019 Class II — MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadi (May 6, 2019)
  • D-1449-2019 Class II — MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, (May 6, 2019)
  • D-1441-2019 Class II — Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: C (May 6, 2019)
  • D-1444-2019 Class II — Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactur (May 6, 2019)
  • D-1443-2019 Class II — Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactu (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)