FDAClass IIMarch 12, 2014

Heparin Sodium Injection recall: Subpotent

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25…

Why was Heparin Sodium Injection recalled?

Subpotent; 18 month time point

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 Number: 6004137, Expiration date: 06/2014

Product
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
161,650 vials
Distribution
Nationwide
Recall date
March 12, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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