FDAClass IIIJuly 17, 2013

Folic Acid Injection recall: Impurity Out of Spec

Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC…

Why was Folic Acid Injection recalled?

Failed Impurities/Degradation Specification

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 #: 6103883, Exp 10/2013

Product
Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
80,480 vials
Distribution
Nationwide and Puerto Rico
Recall date
July 17, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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