Drug Enforcement D-0593-2024

Cross contamination with other products.

Status

Ongoing

Classification

Class III

Report Date

July 17, 2024

Termination Date

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Product Information

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.
Product quantity
8020 vials
Reason for recall
Cross contamination with other products.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Zydus Pharmaceuticals (USA) Inc
Address
73 Route 31 N, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0593-2024
Event ID
94912
Recall initiation date
July 2, 2024
Center classification date
July 10, 2024
Code info
Lot L300269, Exp Date 07/31/2025
More code info
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