FDAClass IIJuly 24, 2013

Oxytocin Injection recall: Subpotent

Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP…

Why was Oxytocin Injection recalled?

Subpotent Drug; 15-month stability test station

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 #: 6003648, Exp. 6/2013

Product
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
221,600 vials
Distribution
Nationwide and Puerto Rico
Recall date
July 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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