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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213

D-0899-2021

September 22, 2021

Class II

Product summary

Firm
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Event
Event 88733
Status
Terminated
Classification
Class II
Quantity
1,347 vials
Official record key
drug-enforcement:D-0899-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot, expiry: Lot #AL07202021@901, Exp 9/18/21; Lot #AL07272021@901, Exp 9/25/21; Lot #AL08032021@901, Exp 10/2/21; Lot #AL08102021@901, Exp 10/9/21; Lot #AL08172021@901, Exp 10/16/21; Lot #AL08242021@901, Exp 10/23/21

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility