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Recall Observatory FDA recall evidence

Drug product

Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ.

D-1028-2013

August 26, 2013

Class II

Product summary

Firm
Pharmacy Creations
Event
Event 66100
Status
Terminated
Classification
Class II
Quantity
50 vials
Official record key
drug-enforcement:D-1028-2013

Official wording

Reason: Lack of Assurance of Sterility: Pharmacy Creations is recalling Lidocaine 1% PF Sterile Injection and EDTA disodium 150 mg/mL due to lack of assurance of sterility.

Code information: Lot # 214490.00, Exp 11/29/2013

Distribution pattern: NJ

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility