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

Recall Number: D-920-2013

Firm: Fresenius Kabi USA, LLC

Classification: Class I

Status: Terminated

Report Date: 20130904

Initiation Date: 20130525

Termination Date: 20160310

Reason for Recall

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

Product Description

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