Drug product
Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
D-320-2016
Product summary
- Event
- Event 72241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 vials
- Official record key
drug-enforcement:D-320-2016
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 #: 062315, Exp 09/23/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility