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Recall Observatory FDA recall evidence

Drug product

Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25

D-0932-2017

February 15, 2017

Class III

Product summary

Firm
Pharmedium Services Llc
Event
Event 77374
Status
Terminated
Classification
Class III
Quantity
147 I.V. pumps
Official record key
drug-enforcement:D-0932-2017

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date

Code information: Lot: 170270192s Lot: 170330167s Lot: 170320087s Ex.: 01/01/1900

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing