FDA Drug recall D-0087-2024
Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 via…
- FDA Drug
- Class II
- terminated
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 via… by Par Sterile Products, citing crystallization; identified as Buprenorphine free base.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0087-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-09 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Par Sterile Products |
| Distribution | US |
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
Reason
Crystallization; identified as Buprenorphine free base
Identifiers
| ndc | 42023-179-05 |
|---|---|
| code_info | 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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Par Sterile Products
- Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distribute…
FDA Drug · Class I · 2024-04-03 · Par Sterile Products - Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready…
FDA Drug · Class II · 2024-01-24 · Par Sterile Products - Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single Dose Vials per carton (NDC 42…
FDA Drug · Class II · 2017-05-17 · Par Sterile Products
All Par Sterile Products recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0087-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.