Home / Recalls / PAR Sterile Products LLC / D-0087-2024

D-0087-2024 Class II Terminated

Recalled by PAR Sterile Products LLC — Rochester, MI

Recall Details

Product Type
Drugs
Report Date
November 15, 2023
Initiation Date
November 9, 2021
Termination Date
September 29, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05

Reason for Recall

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

Distribution Pattern

Nationwide USA

Code Information

Lot No: 343716, Exp. Date: 11/2021; Lot No: 350565, Exp. Date: 07/2022; Lot No: 26921, Exp. Date: 07/2022; Lot No: 36227, Exp. Date: 02/2023

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-0232-2024 Class II — Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 unit (January 11, 2024)
  • D-0698-2017 Class II — Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01) (April 28, 2017)