Drug Enforcement D-0507-2024

Subpotent product in addition to having out-of-specification results for impurities.

Status

Completed

Classification

Class II

Report Date

May 29, 2024

Termination Date

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Product Information

Product description
Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01
Product quantity
2,352 vials
Reason for recall
Subpotent product in addition to having out-of-specification results for impurities.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0507-2024
Event ID
94619
Recall initiation date
May 13, 2024
Center classification date
May 21, 2024
Code info
Lot #: 23061L1C0, Exp 1/31/2025
More code info
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