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Recall Observatory FDA recall evidence

Drug product

Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

D-1038-2013

August 26, 2013

Class II

Product summary

Firm
Leiter's Pharmacy
Event
Event 66103
Status
Terminated
Classification
Class II
Quantity
56 vials
Official record key
drug-enforcement:D-1038-2013

Official wording

Reason: Lack of Assurance of Sterility: Leiter Pharmacy is recalling due bacterial contamination found after investigation at contract testing laboratory discovered that OOS results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Code information: Lot 06072013@49, Exp 9/5/13

Distribution pattern: Nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    bacterial contamination
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility