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Recall Observatory FDA recall evidence

Drug product

Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

D-1123-2015

May 15, 2015

Class II

Product summary

Firm
Montana Compounding Pharmacy
Event
Event 71275
Status
Terminated
Classification
Class II
Quantity
20/1 mL vials
Official record key
drug-enforcement:D-1123-2015

Official wording

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

Code information: Lot 02062015:06@3, expiry date: 5/17/2015; Lot 02272015:93@1, expiry date: 6/30/2015; Lot 03252015:92@7, expiry date: 6/30/2015; Lot 04162015:63@7, expiry date: 6/30/2015.

Distribution pattern: MT and ND

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility