Drug recall
Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc…
FDA recall event 72967 · Class II · Amerita Specialty Infusion Services
Key facts
| Event ID | 72967 |
|---|---|
| Recall numbers | D-0569-2016, D-0570-2016 |
| Recalling firm | Amerita Specialty Infusion Services |
| Product type | Drugs |
| Products | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614, IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | Dec 24, 2015 |
| Report date | Jan 27, 2016 |
| Termination date | Feb 10, 2016 |
| City | Prescott |
| State | AZ |
| Country | United States |
| FEI number | 3012033212 |
At a glance
- 1–9 Products in this recall
- None 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: