FDAClass IISeptember 23, 2015

Ketamine Hydrochloride Injection recall

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

Why was Ketamine Hydrochloride Injection recalled?

Defective Container: There were customer complaints of cracked and leaking glass vials.

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 #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016

Product
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
Recalling firm
Hospira Inc.
Quantity
83,320 vials
Distribution
Nationwide
Recall date
September 23, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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