Home / Recalls / Zydus Pharmaceuticals USA Inc / D-1273-2019

D-1273-2019 Class II Terminated

Recalled by Zydus Pharmaceuticals USA Inc — Pennington, NJ

Recall Details

Product Type: Drugs
Report Date: May 15, 2019
Initiation Date: April 25, 2019
Termination Date: June 29, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3900

Product Description

Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05

Reason for Recall

Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg

Distribution Pattern

Nationwide

Code Information

Z804517, exp Nov 30, 2020

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-1443-2019 Class II — Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactu (May 6, 2019)
D-1453-2019 Class II — MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadi (May 6, 2019)
D-1446-2019 Class II — Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactur (May 6, 2019)
D-1444-2019 Class II — Pramipexole Dihydrochoride Tablets 0.25 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-1450-2019 Class II — MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cad (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-1449-2019 Class II — MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, (May 6, 2019)
D-1452-2019 Class II — Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured (May 6, 2019)