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Recall Observatory FDA recall evidence

Drug product

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

D-0211-2017

September 23, 2016

Class I

Product summary

Firm
Guardian Pharmacy Services
Event
Event 75268
Status
Terminated
Classification
Class I
Quantity
180 syringes
Official record key
drug-enforcement:D-0211-2017

Official wording

Reason: Non-Sterility: failed sterility test result.

Code information: Lot #: 50699:00, Exp 10/04/16

Distribution pattern: Two medical facilities in TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: failed sterility test result.