← FDA ENFORCEMENT
D-0503-2024Class II

American Regent, Inc.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Terminated
Report date
2024-05-29
Distribution
UT only
Firm state
OH
Product quantity
4,136 cartons (10 vials in each carton)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility.

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

Code / lot info

Lot #: 23087N0C0, Exp. Date 11/2024

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.