D-0593-2024Class III

Zydus Pharmaceuticals (USA) Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2024-07-17

Distribution

Nationwide in the USA

Firm state

Product quantity

8020 vials

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Environmental Monitoring

Reason for recall

Cross contamination with other products.

Product description

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.

Code / lot info

Lot L300269, Exp Date 07/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.