FDA Drug recall D-0698-2017
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
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class II recall of 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… by Par Sterile Products, citing crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the bup….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0698-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-28 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Par Sterile Products |
| Distribution | US |
Product
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 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals Companies, Inc., Spring Valley, NY 10977.
Reason
Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the glass vials, which are comprised of principally dextrose and the buprenorphine active component.
Identifiers
| ndc | 42023-179-05 |
|---|---|
| ndc | 42023-179-01 |
| code_info | Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 8218…Lot #: 821102, 821103, Exp 01/18; 821104, 821106, 821107, Exp 02/18; 821108, Exp 03/18; 821884, 821885, Exp 07/18; 821886, 821887, Exp 08/18; 822767, Exp 09/18; 824183, Exp 10/18. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 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 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 · 2023-11-15 · Par Sterile Products
All Par Sterile Products recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0698-2017%22
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