US Drug Recall Register
Class I · High risk Terminated Initiated May 25, 2013 (13 years ago)

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single…

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

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

What was recalled

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

Recalling firm
Fresenius Kabi USA, LLC
NDC code
63323-064-50
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-920-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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