FDAFDA · Food and drugs·Recall number D-920-2013
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
Published September 4, 2013 · Recall initiated: May 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide
- Lot
- Lot #: 6103882, Exp 10/14
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States