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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

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

Agency Publication Date: November 17, 2015
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Affected Products

Product: Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 2839-081715, Exp 11/17/2015

Lot Numbers:
2839-081715
Product: 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 062015, Exp 09/20/2015; 062215, Exp 09/22/2015; 062515, Exp 09/25/2015; and 072115, Exp 10/21/2015

Lot Numbers:
062015
Product: 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 060815, Exp 09/08/2015; 062915, Exp 09/29/2015; 072315, Exp 10/23/2015; and 760-081815, Exp 11/18/2015

Lot Numbers:
060815
Product: BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 071015, Exp 09/10/2015; 072115, Exp 09/21/2015; and 080715, Exp 10/07/2015

Lot Numbers:
071015
Product: Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 062915, Exp 09/29/2015; 070915, Exp 10/09/2015; 073015, Exp 10/30/2015; 080315, Exp 11/03/2015; and 080615, Exp 11/06/2015

Lot Numbers:
062915
Product: Dexamethasone 0.4% Opth Ointment, 3.5 g ointment tubes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 062515, Exp 09/25/2015; and 070615, Exp 10/06/2015

Lot Numbers:
062515
Product: DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 062915, Exp 09/29/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; 073015, Exp 10/30/2015; and 080615, Exp 11/08/2015

Lot Numbers:
060815
Product: Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 071515, Exp 10/15/2015

Lot Numbers:
071515
Product: 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.

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

Lot Numbers:
080415
Product: HCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 080415, Exp 09/04/2015; and 4721-081715, Exp 09/17/2015

Lot Numbers:
080415
Product: HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 080415, Exp 09/04/2015; and 080715, Exp 09/07/2015

Lot Numbers:
080415
Product: HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 081015, Exp 09/10/2015

Lot Numbers:
081015
Product: HCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 081315, Exp 09/13/2015

Lot Numbers:
081315
Product: 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.

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

Lot Numbers:
080615
Product: 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.

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

Lot Numbers:
061215
Product: LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 073115, Exp 10/31/2015

Lot Numbers:
073115
Product: Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072915, Exp 09/13/2015; 080415, Exp 09/19/2015; and 1345-081815, Exp 10/03/2015

Lot Numbers:
072915
Product: Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072715, Exp 09/10/2015; and 073015, Exp 09/13/2015

Lot Numbers:
072715
Product: Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 3327-081715, Exp 09/17/2015

Lot Numbers:
3327-081715
Product: Methylcobalamin 25 mg/mL PF Injection, 0.5 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072915, Exp 09/13/2015

Lot Numbers:
072915
Product: Methylcobalamin 30 mg/mL PF Injection, 0.1 mL prefilled syringes, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072815, Exp 09/10/2015

Lot Numbers:
072815
Product: MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 071315, Exp 10/13/2015

Lot Numbers:
071315
Product: Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 062315, Exp 09/23/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015

Lot Numbers:
062315
Product: Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072915, Exp 10/29/2015

Lot Numbers:
072915
Product: Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 072415, Exp 10/24/2015; and 080715, Exp 11/07/2015

Lot Numbers:
072415
Product: QUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 071315, Exp 09/13/2015

Lot Numbers:
071315
Product: Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 080515, Exp 09/05/2015; 080715, Exp 09/07/2015; 081115, Exp 09/11/2015; and 081415, Exp. Date 09/14/2015

Lot Numbers:
080515
Product: Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

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 09/13/2015; 081515, Exp 09/15/2015; 453-081715, Exp 09/17/2015; 453-081815, Exp 09/18/2015; and 453-081915, Exp 09/19/2015

Lot Numbers:
080415
Product: sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 080415, Exp 09/04/2015

Lot Numbers:
080415
Product: Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 081215, Exp 11/12/2015

Lot Numbers:
081215
Product: Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 060815, Exp 09/08/2015; 061615, Exp 09/16/2015; 070615, Exp 10/06/2015; 071615, Exp 10/16/2015; and 080615, Exp 11/06/2015

Lot Numbers:
060815
Product: Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 070115, Exp 10/01/2015; and 071015, Exp 10/10/2015

Lot Numbers:
070115
Product: Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 062915, Exp 09/29/2015; and 071615, Exp 10/16/2015

Lot Numbers:
062915
Product: Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 060415, Exp 09/04/2015

Lot Numbers:
060415
Product: TRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 071015, Exp 09/10/2015; 071715, Exp 09/17/2015; and 073015, Exp 09/30/2015

Lot Numbers:
071015
Product: TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot # 070815, Exp 09/08/2015; 071715, Exp 09/17/2015; 073115, Exp 10/012015; 080415, Exp 10/04/2015; and 080615, Exp 10/06/2015

Lot Numbers:
070815
Product: TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 070915, Exp 09/09/2015; and 080315, Exp 10/03/2015

Lot Numbers:
070915
Product: TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 070715, Exp 09/07/2015

Lot Numbers:
070715
Product: TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.

Lot #: 073115, Exp 10/01/2015

Lot Numbers:
073115

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 72241
Status: Resolved
Manufacturer: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Manufactured In: United States
Units Affected: 39 products (2 dropper bottles; 4 vials; 35 vials; 5 vials; 7 dropper bottles; 2 ointment tubes; a) 720 vials; b) 4 vials; 1 dropper bottle; 49 vials; 2 vials; 2 vials; 1 vial; 1 vial; 21 vials and 80 prefilled syringes; 76 vials; 1 vial; 10 prefilled syringes; 2 vials; 28 prefilled syringes; 8 prefilled syringes; 30 prefilled syringes; 1 vial; 50 vials; 1 vial; 2 vials; 1 vial; 7 vials; 64 vials; 2 vials; 5 vials; 261 vials; 2 vials; 20 vials; 1 vial; 6 vials; 5 vials; 2 vials; 1 vial; 1 vial)

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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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.