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Recall Observatory FDA recall evidence

Drug product

PROLINE 100MG/ML (PF), 5ML Vials, MEDAUS PHARMACY

D-1233-2016

May 13, 2016

Class II

Product summary

Firm
Medaus, Inc.
Event
Event 74466
Status
Terminated
Classification
Class II
Quantity
60 mL in Vials
Official record key
drug-enforcement:D-1233-2016

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 160308-3, BUD: 09/04/16

Distribution pattern: U.S. Nationwide, Japan, and New Zealand.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility