Compounded Veterinary Drugs on FDA March 16, 2016 FDA Enforcement Report

Veterinary	Cyclosporin 0.2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614	Class II	Lot # 060515, Exp. Date 09/05/2015; Lot # 061215, Exp. Date 09/12/2015; Lot # 062615, Exp. Date 09/26/2015; Lot # 070215, Exp. Date 10/02/2015; Lot # 070615, Exp. Date 10/06/2015; Lot # 072415, Exp. Date 10/24/2015; Lot # 072715, Exp. Date 10/27/2015; and Lot # 081315, Exp. Date 11/13/2015	Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore...	Kalman Health & Wellness, Inc. dba Essential Wellness Pharma  4625 N University St  Peoria, IL 61614-5828
Veterinary	Cyclosporin 1% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614	Class II	Lot # 061515, Exp. Date 09/15/2015; Lot # 062615, Exp. Date 09/26/2015; Lot # 072415, Exp. Date 10/24/2015; Lot # 072715, Exp. Date 10/27/2015; Lot # 073115, Exp. Date 10/31/2015; Lot # 081015, Exp. Date 11/10/2015; and Lot # 081215, Exp. Date 11/12/2015	Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore...	Kalman Health & Wellness, Inc. dba Essential Wellness Pharma  4625 N University St  Peoria, IL 61614-5828
Veterinary	Cyclosporin 2% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614	Class II	Lot # 060815, Exp. Date 09/08/2015; Lot # 070315, Exp. Date 10/03/2015; Lot # 072915, Exp. Date 10/29/2015; and Lot # 080715, Exp. Date 11/07/2015	Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore... Veterinary Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution, packaged in 2.5 mL and 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614 Class II Lot # 062015, Exp. Date 09/20/2015; Lot # 070615, Exp. Date 10/06/2015; Lot # 072315, Exp. Date 10/23/2015; and Lot # 080315, Exp. Date 11/03/2015 Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore... Kalman Health & Wellness, Inc. dba Essential Wellness Pharma  4625 N University St  Peoria, IL 61614-5828 Veterinary Methocarbamol 100mg/mL Injection, packaged in 50 mL sterile glass vials, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614 Class II Lot # 060915, Exp. Date 09/09/2015 Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore... Kalman Health & Wellness, Inc. dba Essential Wellness Pharma  4625 N University St  Peoria, IL 61614-5828 Veterinary Tacrolimus 0.02% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614 Class II Lot # 071415, Exp. Date 09/14/2015; Lot # 071515, Exp. Date 09/15/2015; Lot # 072015, Exp. Date 09/20/2015; Lot # 072315, Exp. Date 09/23/2015; Lot # 080515, Exp. Date 10/05/2015; and Lot # 081215, Exp. Date 10/12/2015 Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore... Kalman Health & Wellness, Inc. dba Essential Wellness Pharma  4625 N University St  Peoria, IL 61614-5828 Veterinary Tacrolimus 0.03% Ophthalmic Solution, packaged in 10 mL plastic dropper bottles, Essential Wellness Pharmacy, 4625 N. University Street, Peoria, IL 61614 Class II Lot # 070315, Exp. Date 09/13/2015; Lot # 071715, Exp. Date 09/15/2015; Lot # 072815, Exp. Date 09/28/2015; Lot # 073115, Exp. Date 09/31/2015; Lot # 080515, Exp. Date 10/05/2015; Lot # 081215, Exp. Date 10/12/2015; and Lot # 081415, Exp. Date 10/14/2015 Lack of sterility assurance: Kalman Health & Wellness, Inc. d.b.a. Essential Wellness Pharmacy 2 is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present amore...