FDA Recall D-0592-2024

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Class III Ongoing 681 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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,

Lot / code: Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025

Quantity: 170,755 vials

Reason for recall

Cross contamination with other products.

Recall record

Recall number: D-0592-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-07-02
Classified by FDA Center: 2024-07-10
FDA published: 2024-07-17
Recalling firm: Zydus Pharmaceuticals (USA) Inc
Firm location: Pennington, NJ

Drug identification

Brand name(s): VERAPAMIL HYDROCHLORIDE
Generic name(s): VERAPAMIL HYDROCHLORIDE
Manufacturer(s): Zydus Pharmaceuticals USA Inc.
NDC(s): 70710-1643, 70710-1644
Route(s): INTRAVENOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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