FDA DrugsClass II
Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Ca...
Published: June 24, 2026Recall ID: D-0596-2026Category: drugsCountry: US
Reason for Recall / Hazard
Crystallization; identified as Buprenorphine free base
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Rochester |
| State | MI |
| Openfda › Unii | 56W8MW3EN1 |
| Openfda › Route › 1 | INTRAMUSCULAR |
| Openfda › Route › 2 | INTRAVENOUS |
| Openfda › Rxcui | 238129 |
| Openfda › Spl id | 32a7af7e-3f90-4881-9075-473644237017 |
| Openfda › Brand name | BUPRENORPHINE HYDROCHLORIDE |
| Openfda › Spl set id | 34767dda-ce52-4f98-a45f-bb5cee0cd5e6 |
| Openfda › Package ndc | 42023-179-05 |
| Openfda › Product ndc | 42023-179 |
| Openfda › Generic name | BUPRENORPHINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUPRENORPHINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Par Health USA, LLC |
| Openfda › Application number | ANDA206586 |
| Openfda › Is original packager | true |
| Event id | 99237 |
| Address 1 | 870 Parkdale Rd |
| Code info | Lot #: 82886, exp 09/30/2026; 89646, exp 05/31/2027 |
| Postal code | 48307-1740 |
| Report date | 20260624 |
| Product type | Drugs |
| Product quantity | 46,334 units |
| Reason for recall | Crystallization; identified as Buprenorphine free base |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260612 |
| Initial firm notification | Letter |
| Center classification date | 20260617 |
Overview
- Recalling FirmPar Health USA, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide in the USA.