RecallRadar

FDA Drug recall 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

On 2018-07-25 the FDA classified a Class II recall of Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag by Avella Of Deer Valley Store 38, citing lack of Assurance of Sterility: Potential leakage of bags.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0956-2018
ClassificationClass II
Statusterminated
Initiated2018-06-12
Published2018-07-25
Last updated2026-09-13 11:52 UTC
CompanyAvella Of Deer Valley Store 38
DistributionUS

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

Reason

Lack of Assurance of Sterility: Potential leakage of bags.

Identifiers

code_info
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 8/8/20…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0956-2018%22

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