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
Product summary
- 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
Lack of Assurance of Sterility