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Recall Observatory FDA recall evidence

Drug 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

D-0087-2024

November 09, 2021

Class II

Product summary

Firm
PAR Sterile Products LLC
Event
Event 89016
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0087-2024

Official wording

Reason: Crystallization; identified as Buprenorphine free base

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

Distribution pattern: Nationwide USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Crystallization; identified as Buprenorphine free base