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Recall Observatory FDA recall evidence

Drug product

Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

D-324-2016

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
7 vials
Official record key
drug-enforcement:D-324-2016

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 #: 080515, Exp 09/05/2015; 080715, Exp 09/07/2015; 081115, Exp 09/11/2015; and 081415, Exp. Date 09/14/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility