Reported May 29, 2024 · Terminated
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For…
American Regent, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Regent, Inc. · 6610 New Albany Rd E · New Albany, OH · 43054-8730
Is this the product you have?
- 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 forCivica, Inc., Lehi, UT 84043
- Mfd byAmerican Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
- Lot codes and dates
Lot #: 23087N0C0Exp. Date 11/2024
- Amount recalled
- 4,136 cartons (10 vials in each carton)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Lack of Assurance of Sterility.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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