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Recall Observatory FDA recall evidence

Drug product

Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

D-328-2016

September 03, 2015

Class II

Product summary

Firm
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Event
Event 72241
Status
Terminated
Classification
Class II
Quantity
261 vials
Official record key
drug-enforcement:D-328-2016

Official wording

Reason: 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.

Code information: Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility