Home / Companies / Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

FDA Regulatory Profile

Summary

Total Recalls
39
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-321-2016Class IIProgesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625September 3, 2015
D-308-2016Class IIHCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHASeptember 3, 2015
D-307-2016Class IIHCG 1000 U/ LIDO 0.2%/mL Injection, packaged in a) 3 mL and b) 8 mL vials, Rx only, Essential WellneSeptember 3, 2015
D-314-2016Class IIMethylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness September 3, 2015
D-304-2016Class IIDUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, EssentiSeptember 3, 2015
D-310-2016Class IIHCG 5000 Units/mL Injection, 0.4 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University,September 3, 2015
D-326-2016Class IIsermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625September 3, 2015
D-334-2016Class IITRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 NSeptember 3, 2015
D-325-2016Class IISermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL September 3, 2015
D-330-2016Class IITestosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential WeSeptember 3, 2015
D-319-2016Class IIMIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 616September 3, 2015
D-331-2016Class IITestosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx September 3, 2015
D-316-2016Class IIMethylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARMSeptember 3, 2015
D-333-2016Class IITRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 462September 3, 2015
D-300-2016Class II17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential WellnSeptember 3, 2015
D-302-2016Class IICyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N.September 3, 2015
D-298-2016Class IIAcetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, EssentiaSeptember 3, 2015
D-309-2016Class IIHCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, PeSeptember 3, 2015
D-336-2016Class IITRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4September 3, 2015
D-335-2016Class IITRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625September 3, 2015