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Recall Observatory FDA recall evidence

Drug product

Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

D-1097-2020

March 26, 2020

Class II

Product summary

Firm
Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy
Event
Event 85351
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1097-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 02212020@2, Expires after 04-21-2020; Lot #: 02262020@52 Expires after 04-26-2020

Distribution pattern: Patient Distribution list includes addresses in the following states: CA, ME, TX

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility