FDA-Drug2022-04-06Class II

TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy

Hazard

Lack of sterility assurance.

Sold states
Nationwide in the USA including Puerto Rico.
Affected count
620 vials
Manufactured in
34911 Us Highway 19 N Ste 600, N/A, Palm Harbor, FL, United States
Products
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0732-2022

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