Home / Recalls / Par Sterile Products LLC / D-0232-2024

D-0232-2024 Class II Ongoing

Recalled by Par Sterile Products LLC — Rochester, MI

Recall Details

Product Type
Drugs
Report Date
January 24, 2024
Initiation Date
January 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1721 cartons

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

Reason for Recall

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

Distribution Pattern

Nationwide USA

Code Information

Lot # 66702; Exp. 02/2025

Other recalls by Par Sterile Products LLC

  • D-0429-2024 Class I — Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous I (March 4, 2024)
  • D-0087-2024 Class II — Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx (November 9, 2021)
  • D-0698-2017 Class II — Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01) (April 28, 2017)