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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530

D-1098-2020

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-1098-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 11152019@41,Expires after 04-07-2020; Lot # 12042019@12, Expires after 04-26-2020; Lot # 12172019@9, Expires after 05-09-2020; Lot # 01032020@49, Expires after 05-26-2020; Lot # 01162020@55, Expires after 06-08-2020

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