Drug product
TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
D-333-2016
Product summary
- Event
- Event 72241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 vials
- Official record key
drug-enforcement:D-333-2016
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 # 070815, Exp 09/08/2015; 071715, Exp 09/17/2015; 073115, Exp 10/012015; 080415, Exp 10/04/2015; and 080615, Exp 10/06/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility