Kalman Health & Wellness, Inc. dba Essential Wellness Pharma: Various Sterile Veterinary Medications Recalled for Lack of Sterility

Agency Publication Date: March 4, 2016

Summary

Kalman Health & Wellness, doing business as Essential Wellness Pharma, is recalling all compounded sterile veterinary preparations within their expiration dates, affecting approximately 635 units. The recall was initiated following an FDA inspection that identified quality control issues that could compromise the sterility of these medications. The affected products include various ophthalmic (eye) solutions and injections such as Cyclosporin, Desmopressin, Methocarbamol, and Tacrolimus sold in Illinois and Iowa.

Risk

If a drug intended to be sterile is contaminated, using it can lead to serious infections in animals, particularly when administered into the eye or through injection. While no injuries have been reported, the lack of sterility assurance means the safety of these products cannot be guaranteed.

What You Should Do

Check your veterinary medications for the following product names and lot numbers: Cyclosporin 0.2%, 1%, or 2% (Lots 060515, 061215, 062615, 070215, 070615, 072415, 072715, 081315, 061515, 073115, 081015, 081215, 060815, 070315, 072915, 080715); Desmopressin 0.01% (Lots 062015, 070615, 072315, 080315); Methocarbamol 100mg/mL (Lot 060915); or Tacrolimus 0.02% or 0.03% (Lots 071415, 071515, 072015, 072315, 080515, 081215, 070315, 071715, 072815, 073115, 081415).
Immediately stop using any of the affected medications for your animals.
Contact your veterinarian or pharmacist to discuss alternative treatments and to report any health issues observed in your pet.
Return any unused portions of the recalled medications to Essential Wellness Pharmacy (4625 N. University Street, Peoria, IL 61614) for a refund and contact the manufacturer at their business location for further guidance.
For additional questions, contact the FDA’s Center for Veterinary Medicine at 240-402-7002.

Your Remedy Options

Full Refund

Veterinary drug refund instructions

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cyclosporin 0.2% Ophthalmic Solution (10 mL)

Model:

V-394-2016

Lot Numbers:

060515 (Exp. 09/05/2015)

061215 (Exp. 09/12/2015)

062615 (Exp. 09/26/2015)

070215 (Exp. 10/02/2015)

070615 (Exp. 10/06/2015)

072415 (Exp. 10/24/2015)

072715 (Exp. 10/27/2015)

081315 (Exp. 11/13/2015)

Date Ranges: 09/05/2015 - 11/13/2015

Product: Cyclosporin 1% Ophthalmic Solution (10 mL)

Model:

V-395-2016

Lot Numbers:

061515 (Exp. 09/15/2015)

062615 (Exp. 09/26/2015)

072415 (Exp. 10/24/2015)

072715 (Exp. 10/27/2015)

073115 (Exp. 10/31/2015)

081015 (Exp. 11/10/2015)

081215 (Exp. 11/12/2015)

Date Ranges: 09/15/2015 - 11/12/2015

Product: Cyclosporin 2% Ophthalmic Solution (10 mL)

Model:

V-396-2016

Lot Numbers:

060815 (Exp. 09/08/2015)

070315 (Exp. 10/03/2015)

072915 (Exp. 10/29/2015)

080715 (Exp. 11/07/2015)

Date Ranges: 09/08/2015 - 11/07/2015

Product: Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution (2.5 mL / 10 mL)

Model:

V-397-2016

Lot Numbers:

062015 (Exp. 09/20/2015)

070615 (Exp. 10/06/2015)

072315 (Exp. 10/23/2015)

080315 (Exp. 11/03/2015)

Date Ranges: 09/20/2015 - 11/03/2015

Product: Methocarbamol 100mg/mL Injection (50 mL)

Model:

V-398-2016

Lot Numbers:

060915 (Exp. 09/09/2015)

Date Ranges: 09/09/2015

Product: Tacrolimus 0.02% Ophthalmic Solution (10 mL)

Model:

V-399-2016

Lot Numbers:

071415 (Exp. 09/14/2015)

071515 (Exp. 09/15/2015)

072015 (Exp. 09/20/2015)

072315 (Exp. 09/23/2015)

080515 (Exp. 10/05/2015)

081215 (Exp. 10/12/2015)

Date Ranges: 09/14/2015 - 10/12/2015

Product: Tacrolimus 0.03% Ophthalmic Solution (10 mL)

Model:

V-400-2016

Lot Numbers:

070315 (Exp. 09/13/2015)

071715 (Exp. 09/15/2015)

072815 (Exp. 09/28/2015)

073115 (Exp. 09/31/2015)

080515 (Exp. 10/05/2015)

081215 (Exp. 10/12/2015)

081415 (Exp. 10/14/2015)

Date Ranges: 09/13/2015 - 10/14/2015

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72501

Status: Resolved

Manufacturer: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Sold By: Essential Wellness Pharmacy

Manufactured In: United States

Units Affected: 7 products (80 mL; 130 mL; 40 mL; 25 mL; 100 mL; 170 mL; 90 mL)

Distributed To: Illinois, Iowa

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

Summary

What You Should Do

Check your veterinary medications for the following product names and lot numbers: Cyclosporin 0.2%, 1%, or 2% (Lots 060515, 061215, 062615, 070215, 070615, 072415, 072715, 081315, 061515, 073115, 081015, 081215, 060815, 070315, 072915, 080715); Desmopressin 0.01% (Lots 062015, 070615, 072315, 080315); Methocarbamol 100mg/mL (Lot 060915); or Tacrolimus 0.02% or 0.03% (Lots 071415, 071515, 072015, 072315, 080515, 081215, 070315, 071715, 072815, 073115, 081415).

Immediately stop using any of the affected medications for your animals.

Contact your veterinarian or pharmacist to discuss alternative treatments and to report any health issues observed in your pet.

Return any unused portions of the recalled medications to Essential Wellness Pharmacy (4625 N. University Street, Peoria, IL 61614) for a refund and contact the manufacturer at their business location for further guidance.

For additional questions, contact the FDA’s Center for Veterinary Medicine at 240-402-7002.

Affected Products

Product: Cyclosporin 0.2% Ophthalmic Solution (10 mL)

Model:

V-394-2016

Lot Numbers:

060515 (Exp. 09/05/2015)

061215 (Exp. 09/12/2015)

062615 (Exp. 09/26/2015)

070215 (Exp. 10/02/2015)

070615 (Exp. 10/06/2015)

072415 (Exp. 10/24/2015)

072715 (Exp. 10/27/2015)

081315 (Exp. 11/13/2015)

Date Ranges: 09/05/2015 - 11/13/2015

Product: Cyclosporin 1% Ophthalmic Solution (10 mL)

Model:

V-395-2016

Lot Numbers:

061515 (Exp. 09/15/2015)

062615 (Exp. 09/26/2015)

072415 (Exp. 10/24/2015)

072715 (Exp. 10/27/2015)

073115 (Exp. 10/31/2015)

081015 (Exp. 11/10/2015)

081215 (Exp. 11/12/2015)

Date Ranges: 09/15/2015 - 11/12/2015

Product: Cyclosporin 2% Ophthalmic Solution (10 mL)

Model:

V-396-2016

Lot Numbers:

060815 (Exp. 09/08/2015)

070315 (Exp. 10/03/2015)

072915 (Exp. 10/29/2015)

080715 (Exp. 11/07/2015)

Date Ranges: 09/08/2015 - 11/07/2015

Product: Desmopressin (Desmopressin Acetate) 0.01% Ophthalmic solution (2.5 mL / 10 mL)

Model:

V-397-2016

Lot Numbers:

062015 (Exp. 09/20/2015)

070615 (Exp. 10/06/2015)

072315 (Exp. 10/23/2015)

080315 (Exp. 11/03/2015)

Date Ranges: 09/20/2015 - 11/03/2015

Product: Methocarbamol 100mg/mL Injection (50 mL)

Model:

V-398-2016

Lot Numbers:

060915 (Exp. 09/09/2015)

Date Ranges: 09/09/2015

Product: Tacrolimus 0.02% Ophthalmic Solution (10 mL)

Model:

V-399-2016

Lot Numbers:

071415 (Exp. 09/14/2015)

071515 (Exp. 09/15/2015)

072015 (Exp. 09/20/2015)

072315 (Exp. 09/23/2015)

080515 (Exp. 10/05/2015)

081215 (Exp. 10/12/2015)

Date Ranges: 09/14/2015 - 10/12/2015

Product: Tacrolimus 0.03% Ophthalmic Solution (10 mL)

Model:

V-400-2016

Lot Numbers:

070315 (Exp. 09/13/2015)

071715 (Exp. 09/15/2015)

072815 (Exp. 09/28/2015)

073115 (Exp. 09/31/2015)

080515 (Exp. 10/05/2015)

081215 (Exp. 10/12/2015)

081415 (Exp. 10/14/2015)

Date Ranges: 09/13/2015 - 10/14/2015

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 72501

Status: Resolved

Manufacturer: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Sold By: Essential Wellness Pharmacy

Manufactured In: United States

Units Affected: 7 products (80 mL; 130 mL; 40 mL; 25 mL; 100 mL; 170 mL; 90 mL)

Distributed To: Illinois, Iowa