FDAClass ISeptember 4, 2013

Magnesium Sulfate Injection recall: Particulate Matter

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…

Why was Magnesium Sulfate Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 6103882, Exp 10/14

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…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
15,625 vials
Distribution
Nationwide
Recall date
September 4, 2013
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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