Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single...
FDA Recall #D-0087-2024 — Class II — November 9, 2021
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.
Recalling Firm
PAR Sterile Products LLC — Rochester, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated