Drug recall
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only…
FDA recall event 65218 · Class I · Fresenius Kabi USA, LLC
Key facts
| Event ID | 65218 |
|---|---|
| Recall numbers | D-920-2013 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Product type | Drugs |
| Products | Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review. |
| Initiation date | May 25, 2013 |
| Report date | Sep 4, 2013 |
| Termination date | Mar 10, 2016 |
| City | Lake Zurich |
| State | IL |
| Country | United States |
| FEI number | 3002733956 |
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: