niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenou
Summary
The FDA issued a Class II for niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Si by American Regent, Inc.. Reason: Lack of Assurance of Sterility..
Details
Source
Drug Recall
External ID
D-0503-2024
Action Date
2024-05-29
Status
Terminated
Category
drug
Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Lot/Code Info: Lot #: 23087N0C0, Exp. Date 11/2024
Quantity Affected: 4,136 cartons (10 vials in each carton)
Reason for Recall
Lack of Assurance of Sterility.
Distribution
UT only
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-14
Company
New Albany, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
American Regent, Inc. has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (American Regent, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Regent, Inc. have FDA actions?
American Regent, Inc. has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0503-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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