Verapamil Hydrochloride Injection, Solution
FDA Recall NDC 70710-1644
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Verapamil Hydrochloride (NDC 70710-1644). A significant event, classified as Class III, was initiated on Jul 02, 2024 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Cross contamination with other products."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Cross contamination with other products.
Jul 02, 2024
Jul 17, 2024
8020 vials
Recall Profile & Regulatory Data
Event ID
94912
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# Lot L300269, Exp Date 07/31/2025
Affected Packages Involved in this Recall
70710-1643-5Product
70710-1643-7Product
70710-1644-1Product
70710-1644-5Product
Class III Ongoing
Cross contamination with other products.
Jul 02, 2024
Jul 17, 2024
170,755 vials
Recall Profile & Regulatory Data
Event ID
94912
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Zydus Pharmaceuticals (USA) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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,
Batch or Lot Expiration Information
Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025
Affected Packages Involved in this Recall
70710-1643-5Product
70710-1643-7Product
70710-1644-1Product
70710-1644-5Product
70710-1643-1Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
