FDAClass IIMay 8, 2013

Diazepam Injection recall: Sterility Concern

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

Why was Diazepam Injection recalled?

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

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 17-100-EV and 17-399-EV

Product
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Recalling firm
Hospira Inc.
Quantity
172,350 vials
Distribution
Nationwide and Puerto Rico
Recall date
May 8, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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