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Recall Observatory FDA recall evidence

Drug product

Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

D-325-2016

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
64 vials
Official record key
drug-enforcement:D-325-2016

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 #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/13/2015; 081515, Exp 09/15/2015; 453-081715, Exp 09/17/2015; 453-081815, Exp 09/18/2015; and 453-081915, Exp 09/19/2015

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility