FDAClass IIJuly 25, 2018

Midazolam 0.5mg/mL recall: Sterility Concern

Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By…

Why was Midazolam 0.5mg/mL recalled?

Lack of Assurance of Sterility: Potential leakage of bags.

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 #:5/21/18 0506 240-40810P, BUD 8/4/2018; 5/22/18 0501 86-40810P, BUD 8/5/2018; 5/25/18 0900 410-40810P, BUD 8/8/2018; 6/6/18 0836 86-40810P, BUD 8/20/2018.

Product
Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By…
Recalling firm
Avella of Deer Valley, Inc. Store 38
Quantity
220 bags
Distribution
Nationwide in the USA
Recall date
July 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls