← FDA ENFORCEMENT
D-0232-2024Class II

Par Sterile Products LLC

Recalling firm
Par Sterile Products LLC
Product type
Drug
Status
Ongoing
Report date
2024-01-24
Distribution
Nationwide USA
Firm state
MI
Product quantity
1721 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.

Product description

Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10

Code / lot info

Lot # 66702; Exp. 02/2025

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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.