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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213

D-0944-2023

July 13, 2023

Class II

Product summary

Firm
New Vitalis Pharmacy LLC dba New Vitalis Pharmacy
Event
Event 92699
Status
Ongoing
Classification
Class II
Quantity
102 vials
Official record key
drug-enforcement:D-0944-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: AL-05222023@901, BUD 7/22/23; AL-06122023@908CS, BUD 8/11/23

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility