Par Health USA, LLC: Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or In…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-24 |
| 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 / hazard | Crystallization; identified as Buprenorphine free base |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0596-2026 |