Drug recall
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug…
FDA recall event 80453 · Class II · Medi-Fare Drug and Home Health Center
Key facts
| Event ID | 80453 |
|---|---|
| Recall numbers | D-0919-2018 |
| Recalling firm | Medi-Fare Drug and Home Health Center |
| Product type | Drugs |
| Products | Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL. |
| Initiation date | Jul 3, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | Apr 3, 2019 |
| City | Blacksburg |
| State | SC |
| Country | United States |
| FEI number | 3009925820 |
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: