FDA-Drug2013-09-04Class I

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

Fresenius Kabi USA, LLC
Hazard

Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

Sold states
Nationwide
Affected count
15,625 vials
Manufactured in
3 Corporate Dr, Lake Zurich, IL, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-920-2013

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