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Recall Observatory FDA recall evidence

Drug product

Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99

D-0788-2016

February 12, 2016

Class II

Product summary

Firm
Walter's Pharmacy
Event
Event 73336
Status
Terminated
Classification
Class II
Quantity
5 bottles
Official record key
drug-enforcement:D-0788-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 010516, 012016

Distribution pattern: PA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility