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Recall Observatory FDA recall evidence

Drug 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

D-0956-2018

June 12, 2018

Class II

Product summary

Firm
Avella of Deer Valley, Inc. Store 38
Event
Event 80307
Status
Terminated
Classification
Class II
Quantity
220 bags
Official record key
drug-enforcement:D-0956-2018

Official wording

Reason: Lack of Assurance of Sterility: Potential leakage of bags.

Code information: 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.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility