Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactur
Summary
The FDA issued a Class III for Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-D by Zydus Pharmaceuticals (USA) Inc. Reason: Cross contamination with other products..
Details
Source
Drug Recall
External ID
D-0593-2024
Action Date
2024-07-17
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot L300269, Exp Date 07/31/2025
Quantity Affected: 8020 vials
Reason for Recall
Cross contamination with other products.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-02
Company
Pennington, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 61 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zydus Pharmaceuticals (USA) Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zydus Pharmaceuticals (USA) Inc have FDA actions?
Zydus Pharmaceuticals (USA) Inc has 47 FDA actions in our database, including 47 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0593-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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