Drug recall
Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-01), packaged in 1 mL x 5 Single…
FDA recall event 77169 · Class II · PAR Sterile Products LLC
Key facts
| Event ID | 77169 |
|---|---|
| Recall numbers | D-0698-2017 |
| Recalling firm | PAR Sterile Products LLC |
| Product type | Drugs |
| 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 42023-179-05), Rx Only, Distributed by: Par Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Apr 28, 2017 |
| Report date | May 17, 2017 |
| Termination date | Mar 29, 2018 |
| City | Rochester |
| State | MI |
| Country | United States |
| FEI number | 1818977 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: