FDA-Drug2015-11-25Class II

Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Hazard

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Sold states
Nationwide
Affected count
2 vials
Manufactured in
4625 N University St, N/A, Peoria, IL, United States
Products
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-329-2016

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