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Recall Observatory FDA recall evidence

Drug product

HYALURONIDASE, 240 u/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0197-2015

October 06, 2014

Class II

Product summary

Firm
Oregon Compounding Centers, Inc. dba Creative Compounds
Event
Event 69519
Status
Terminated
Classification
Class II
Quantity
10 mL
Official record key
drug-enforcement:D-0197-2015

Official wording

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Code information: Lot #: 20140818@27, discard date: 2/21/2015

Distribution pattern: Oregon, Washington

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility