Drug recall D-920-2013

Class I Terminated reported Sep 4, 2013

Product

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

Reason for recall

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

Lots and codes

Lot #: 6103882, Exp 10/14

Recall details

Recalling firm
Fresenius Kabi USA, LLC, Lake Zurich, IL
Quantity
15,625 vials
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
May 25, 2013
Terminated
March 10, 2016

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