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FDAFDA · Food and drugs·Recall number D-0956-2018

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: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10

Published July 25, 2018 · Recall initiated: June 12, 2018

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Lack of Assurance of Sterility: Potential leakage of bags.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Avella of Deer Valley, Inc. Store 38
Distributor
Nationwide in the USA
Lot
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.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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