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Recall Observatory FDA recall evidence

Drug product

Hydromorphone HCL 25 mg/ml/Bupivacaine HCL 4 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA

D-0757-2016

February 04, 2016

Class II

Product summary

Firm
Hartley Medical Center Pharmacy, Incorporated
Event
Event 73304
Status
Terminated
Classification
Class II
Quantity
1 syringe
Official record key
drug-enforcement:D-0757-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: BUD: 5/3/2016

Distribution pattern: Nationwide. No foreign distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility