Buprenorphine HCI Injection — Class II drug recall D-0698-2017
Terminated recall by PAR Sterile Products LLC, reported 2017-05-17, distributed nationwide. Crystallization: due to the presence of white, crystalline particulates, adhered to the side and bottom of the
| Recall number | D-0698-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PAR Sterile Products LLC, Rochester, MI, United States |
| Recall initiated | 2017-04-28 |
| Classified | 2017-05-09 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 122,469 cartons |
| Reason classes | foreign material, specification failure |
| NDC | 42023-0179, 42023-0179-01, 42023-0179-05 |
| Lot numbers | 01/18, 02/18, 03/18, 07/18, 08/18, 09/18, 10/18, 821102, 821103, 821104, 821106, 821107, 821108, 821884, 821885, 821886, 821887, 822767, 824183 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0698-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.