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Recall Observatory FDA recall evidence

Drug product

Lidocaine/Phenylephrine PF 1%/1.5% Injectible vials, 1 mL Single Use Vial, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126

D-1041-2013

August 26, 2013

Class II

Product summary

Firm
Leiter's Pharmacy
Event
Event 66103
Status
Terminated
Classification
Class II
Quantity
728 vials
Official record key
drug-enforcement:D-1041-2013

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/failed results were reported to customers as passing. Hence the sterility of these products cannot be assured.

Code information: Lot # : 07302013@6 Exp 10/28/13

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