January 2024 FDA Recall Vasostrict by Par Sterile Products Llc
D-0232-2024 - Superpotent Drug
This Class II drug recall was voluntarily initiated by Par Sterile Products Llc on January 11, 2024 for the product Vasostrict. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0232-2024
Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
01-11-2024
01-24-2024
1721 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Par Sterile Products LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 66702; Exp. 02/2025
