PAR Sterile Products LLC: Drug Recall

Recall #D-0087-2024 · 11/09/2021

Class II: Risk

Recall Details

Recall Number: D-0087-2024
Classification: Class II
Product Type: Drug
Recalling Firm: PAR Sterile Products LLC
Status: Terminated
Date Initiated: 11/09/2021
Location: Rochester, MI, United States
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

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

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

Distribution Pattern

Nationwide USA

Other Recalls by PAR Sterile Products LLC

Class I: Dangerous 03/04/2024

Presence of Particulate Matter.
Class II: Risk 01/11/2024

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

View all recalls by PAR Sterile Products LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.