Drug recall
Buprenorphine HCL INJ Preserved, 12mg/20mL (0.6mg/mL), 20mL MDV, Rx only, Premier Pharmacy Labs, 8265…
FDA recall event 83172 · Class II · Premier Pharmacy Labs Inc
Key facts
| Event ID | 83172 |
|---|---|
| Recall numbers | V-0227-2019 |
| Recalling firm | Premier Pharmacy Labs Inc |
| Product type | Veterinary |
| Products | Buprenorphine HCL INJ Preserved, 12mg/20mL (0.6mg/mL), 20mL MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-703-37, barcode 6 69623 70337 0. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of… |
| Initiation date | Jun 17, 2019 |
| Report date | Sep 25, 2019 |
| Termination date | Oct 26, 2021 |
| City | Weeki Wachee |
| State | FL |
| Country | United States |
| FEI number | 3007271263 |
At a glance
- 1–9 Products in this recall
- 1–9 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: