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Recall Observatory FDA recall evidence

Drug product

Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

D-1258-2019

April 08, 2019

Class II

Product summary

Firm
Customceutical Compounding
Event
Event 82615
Status
Terminated
Classification
Class II
Quantity
8 vials
Official record key
drug-enforcement:D-1258-2019

Official wording

Reason: Lack of assurance of sterility for injectables and solutions intended to be sterile.

Code information: Lot #: 01232019@25, Exp 4/23/19

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility