FDAClass IIFebruary 8, 2017

Midazolam Injection recall: Impurity Out of Spec

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC…

Why was Midazolam Injection recalled?

Failed Impurities/Degradation Specifications

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 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017

Product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
47, 020 vials
Distribution
Nationwide and Puerto Rico
Recall date
February 8, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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