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Recall Observatory FDA recall evidence

Drug product

Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78

D-0792-2016

February 12, 2016

Class II

Product summary

Firm
Walter's Pharmacy
Event
Event 73336
Status
Terminated
Classification
Class II
Quantity
4 bottles
Official record key
drug-enforcement:D-0792-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 012216, 012616, 012816, 020316, 020616;

Distribution pattern: PA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility