Drug Enforcement D-0232-2024

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

Status

Ongoing

Classification

Class II

Report Date

January 24, 2024

Termination Date

—

Product Information

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
Product quantity
1721 cartons
Reason for recall
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
PAR Sterile Products LLC
Address
870 Parkdale Rd, N/A

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

Codes & Dates

Recall number
D-0232-2024
Event ID
93805
Recall initiation date
January 11, 2024
Center classification date
January 16, 2024
Code info
Lot # 66702; Exp. 02/2025
More code info
—