D-306-2016 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
- 49 vials
Product Description
HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 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 #: 080415, Exp 09/04/2015; 080515, Exp 09/05/2015; 080615, Exp 09/06/2015; 080715, Exp 09/07/2015; 081015, Exp 09/10/2015; 081115, Exp 09/11/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1702-081715, Exp 09/17/2015; 1702-081815, Exp 09/18/2015; and 1702-081915, Exp 09/19/2015