FDA recall D-0592-2024

Zydus Pharmaceuticals (USA) Inc · Class III · drug

Product

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,

Reason for recall

Cross contamination with other products.

Distribution

Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-07-02
Report date
2024-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0592-2024