FDA recall record

Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per recall — FDA D-0593-2024

Cross contamination with other products.

Class IIIclassification
D-0593-2024official record ID
Jul 17, 2024report date

Recall record at a glance

Official recordD-0593-2024
CategoryDrug Recalls
ClassificationClass III
FDA record statusOngoing
Recalling firmZydus Pharmaceuticals (USA) Inc.
Report dateJul 17, 2024
Recall initiation dateJul 2, 2024
Quantity8020 vials
LocationPennington, NJ, United States

Official 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.

Why the product was recalled

Cross contamination with other products.

Distribution information

Nationwide in the USA

How to read the classification

FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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