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Recall Observatory FDA recall evidence

Drug product

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1119-2015

May 15, 2015

Class II

Product summary

Firm
Montana Compounding Pharmacy
Event
Event 71275
Status
Terminated
Classification
Class II
Quantity
259/0.05 mL Syringes
Official record key
drug-enforcement:D-1119-2015

Official wording

Reason: Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

Code information: Lot 04202015:49@1, Expiry date: 5/20/2015; Lot 04272015:06@6, Expiry date: 6/2/2015; Lot 04282015:16@13, Expiry date: 6/12/2015; Lot 05062015:56@3, Expiry date: 5/24/2015;

Distribution pattern: MT and ND

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility