Recall D-0596-2026

US Class II Ongoing · initiated 2026-06-12

Recalling firm

Par Health USA, LLC, MI

Product

Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05

Reason for recall

Crystallization; identified as Buprenorphine free base

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