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Recall Observatory FDA recall evidence

Drug product

METHYCOBALAMIN, preservative free, 20mg/mL, injectable, 0.3 mL or 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

D-0204-2015

October 06, 2014

Class II

Product summary

Firm
Oregon Compounding Centers, Inc. dba Creative Compounds
Event
Event 69519
Status
Terminated
Classification
Class II
Quantity
119/0.3 mL vials and 106/1 mL vials
Official record key
drug-enforcement:D-0204-2015

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 #: 20140718@2/0.3, discard date: 1/14/2015; Lot #: 20140808@4/0.3, discard date: 2/4/2015; Lot #: 20140902@36/1, discard date: 3/1/2015; Lot #: 20140902@37/0.3, discard date: 3/1/2015; Lot #: 20140912@22/1, discard date: 3/11/2015.

Distribution pattern: Oregon, Washington

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Sterility