D-300-2016 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2015
- Initiation Date
- September 3, 2015
- Termination Date
- December 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 vials
Product Description
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Reason for Recall
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.
Distribution Pattern
Nationwide
Code Information
Lot #: 060815, Exp 09/08/2015; 062915, Exp 09/29/2015; 072315, Exp 10/23/2015; and 760-081815, Exp 11/18/2015