D-312-2016 Class II Terminated
FDA drug recall D-312-2016 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: 76 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
- 76 vials
Product Description
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 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 #: 061215, Exp 09/12/2015; 061915, Exp 09/19/2015; 070115, Exp 10/01/2015; 072315, Exp 10/23/2015; and 073115, Exp 10/31/2015