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Recall Observatory FDA recall evidence

Drug product

0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) a.) 1 mL in 3 mL BD Syringe, 10 per carton, b.) 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate) 5 mL in 5 mL BD Syringe, 10 per carton Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478.

D-0374-2019

January 02, 2019

Class II

Product summary

Firm
PharMEDium Services, LLC.
Event
Event 81895
Status
Terminated
Classification
Class II
Quantity
7,711 syringes
Official record key
drug-enforcement:D-0374-2019

Official wording

Reason: Subpotent

Code information: Service Code 2K2466 and 2K2470 183320004S, 183330008S, 183340002S, 183340003S, 183300004S, 183310007S, 183370041S, 183310043S, 183370042S, 183320003S, 183380007S, 183250013S, 183250014S, 183320005S, 183330009S, 183370007S, 183390044S, 183400006S, 183410003S.

Distribution pattern: Product was distributed throughout the United States.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent