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 Intravenous use, Manufac
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Par Health USA, LLC
- 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
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA.
- Recall initiated
- 2026-06-12
- Code info
- Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027
- Product quantity
- 46,334 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Rochester
- State
- MI
- Country
- United States
- Event id
- 99237
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