Drug recall D-0087-2024

Class II Terminated reported Nov 15, 2023

Product

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; identified as Buprenorphine free base

Lots and codes

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

Recall details

Recalling firm
PAR Sterile Products LLC, Rochester, MI
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
November 9, 2021
Terminated
September 29, 2024

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