Drug Enforcement D-0503-2024

Lack of Assurance of Sterility.

Status

Completed

Classification

Class II

Report Date

May 29, 2024

Termination Date

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Product Information

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
Product quantity
4,136 cartons (10 vials in each carton)
Reason for recall
Lack of Assurance of Sterility.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
UT only

Location & Firm

Recalling firm
American Regent, Inc.
Address
6610 New Albany Rd E

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0503-2024
Event ID
94621
Recall initiation date
May 14, 2024
Center classification date
May 21, 2024
Code info
Lot #: 23087N0C0, Exp. Date 11/2024
More code info
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