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Recall Observatory FDA recall evidence

Drug product

Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110.

D-66200-001

September 05, 2013

Class II

Product summary

Firm
Fallon Wellness Pharmacy Llc
Event
Event 66200
Status
Terminated
Classification
Class II
Quantity
241 prefilled syringes
Official record key
drug-enforcement:D-66200-001

Official wording

Reason: Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate.

Code information: Lot #: 08052013@84, Exp 11/5/2013

Distribution pattern: NY & ME

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility