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Recall Observatory FDA recall evidence

Drug product

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

D-0295-2015

September 27, 2012

Class II

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 63451
Status
Terminated
Classification
Class II
Quantity
101,200 Vials
Official record key
drug-enforcement:D-0295-2015

Official wording

Reason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.

Code information: Lot 6003827, Exp. Date 04/2015

Distribution pattern: U.S. Nationwide Including Puerto Rico

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    glass particles
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility