FDAClass IIIAugust 19, 2015

Hydralazine Hydrochloride Injection recall

Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street…

Why was Hydralazine Hydrochloride Injection recalled?

Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)

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 #: 6110593, Exp 11/2016

Product
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street…
Recalling firm
Fresenius Kabi USA, LLC
Quantity
93,000 vials
Distribution
Nationwide
Recall date
August 19, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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