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Recall Observatory FDA recall evidence

Drug product

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.

D-0096-2017

September 16, 2016

Class II

Product summary

Firm
Hospira Inc., A Pfizer Company
Event
Event 75156
Status
Terminated
Classification
Class II
Quantity
15 vials
Official record key
drug-enforcement:D-0096-2017

Official wording

Reason: Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.

Code information: Lot #: 60295DD, Ep 1DEC2017

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility