FDAClass IIMarch 27, 2019

Midazolam Benzodiazepine 50 mg/50 mL recall: Sterility Concern

Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05…

Why was Midazolam Benzodiazepine 50 mg/50 mL recalled?

Lack of Assurance of Sterility

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?

Lots: 12/03/18 9479 40105P Exp. 4/2/2019; 12/3/18 6583 40105P Exp. 4/2/2019; 12/3/18 8918 40105P Exp. 4/2/2019; 12/03/18 4727 40105P Exp. 4/2/2019

Product
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05…
Recalling firm
Advanced Pharma Inc.
Quantity
1125 bags
Distribution
Nationwide
Recall date
March 27, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls