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Recall Observatory FDA recall evidence

Drug product

Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25

D-0955-2017

June 22, 2017

Class II

Product summary

Firm
Advanced Pharma Inc.
Event
Event 77595
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0955-2017

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 5/31/17 1416 382-92425P BUD: 8/29/2017

Distribution pattern: Nationwide with the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility