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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

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
Recall Number D-920-2013
Classification Class I
Code Info Lot #: 6103882, Exp 10/14
Product Distributed Qty 15,625 vials
Reason For Recall Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.

Event Detail

Event Id 65218
Product Type Drugs
Status Ongoing
Recalling Firm Fresenius Kabi USA, LLC
City Lake Zurich
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide