FDAFDA · Food and drugs·Recall number D-304-2016
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Published November 25, 2015 · Recall initiated: September 3, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Distributor
- Nationwide
- Lot
- Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; 073015, Exp 10/30/2015; and 080615, Exp 11/08/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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