D-299-2016 Class II Terminated
FDA drug recall D-299-2016 was initiated by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma on September 3, 2015 and is designated Class II. 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 l… The recall status is terminated (terminated December 29, 2017). Affected quantity: 4 vials.
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
- 4 vials
Product Description
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor 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 #: 062015, Exp 09/20/2015; 062215, Exp 09/22/2015; 062515, Exp 09/25/2015; and 072115, Exp 10/21/2015