D-311-2016 Class II Terminated
FDA drug recall D-311-2016 was initiated by Kalman Health & Wellness, Inc. Dba Essential Wellness Pharma on Sep 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… The recall status is terminated (terminated Dec 29, 2017). Affected quantity: 21 vials and 80 prefilled syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 25, 2015
- Initiation Date
- Sep 3, 2015
- Termination Date
- Dec 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 vials and 80 prefilled syringes
Product Description
HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1.2 mL, c) 1.6 mL, d) 2.0 mL, e) 2.4 mL, f) 3.6 mL, g) 4 mL, h) 4.8 mL vials; and i) 0.1 mL, j) 0. 2 mL, k) 0.3 mL prefilled syringes, 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 #: 080615, Exp 09/06/2015; 081215, Exp 09/12/2015; 081315, Exp 09/13/2015; 081415, Exp 09/14/2015; 1730-081715, Exp 09/17/2015; 1730-081815, Exp 09/18/2015; and 1730-081915, Exp 09/19/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-311-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026