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Recall Observatory FDA recall evidence

Drug product

Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ 85205

D-1218-2014

December 12, 2013

Class II

Product summary

Firm
Zions RX Formulations Services LLC dba RX Formuations Serv.
Event
Event 67080
Status
Terminated
Classification
Class II
Quantity
60 units
Official record key
drug-enforcement:D-1218-2014

Official wording

Reason: Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.

Code information: Lot #: 117456@3 Expiration Date: 12/12/2013 Lot #: 117907@3 Expiration Date: 12/19/2013 Lot #: 118297@8 Expiration Date: 12/25/2013

Distribution pattern: AZ

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility