← FDA ENFORCEMENT
D-0507-2024Class II

American Regent, Inc.

Recalling firm
American Regent, Inc.
Product type
Drug
Status
Terminated
Report date
2024-05-29
Distribution
USA Nationwide
Firm state
OH
Product quantity
2,352 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

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

Code / lot info

Lot #: 23061L1C0, Exp 1/31/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

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.