Drug recall
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United…
FDA recall event 78183 · Class II · United Pharmacy
Key facts
| Event ID | 78183 |
|---|---|
| Recall numbers | D-0008-2018 |
| Recalling firm | United Pharmacy |
| Product type | Drugs |
| Products | Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed |
| Initiation date | Sep 27, 2017 |
| Report date | Oct 18, 2017 |
| Termination date | Mar 29, 2018 |
| City | West Palm Beach |
| State | FL |
| Country | United States |
| FEI number | 3010404505 |
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: