Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma appears in FDA public data with 39 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-321-2016, Class II) was initiated on September 3, 2015.
Summary
- Total Recalls
- 39
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-321-2016 | Class II | Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 | September 3, 2015 |
| D-308-2016 | Class II | HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential Wellness PHA | September 3, 2015 |
| D-314-2016 | Class II | Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essential Wellness | September 3, 2015 |
| D-304-2016 | Class II | DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essenti | September 3, 2015 |
| D-326-2016 | Class II | sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 | September 3, 2015 |
| D-325-2016 | Class II | Sermorelin 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-330-2016 | Class II | Testosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential We | September 3, 2015 |
| D-331-2016 | Class II | Testosterone 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-316-2016 | Class II | Methylcobalamin 20 mg/mL PF Injection, 0.05 mL prefilled syringes, Rx only, Essential Wellness PHARM | September 3, 2015 |
| D-333-2016 | Class II | TRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 462 | September 3, 2015 |
| D-300-2016 | Class II | 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Essential Welln | September 3, 2015 |
| D-302-2016 | Class II | Cyclosporin 0.1% Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 4625 N. | September 3, 2015 |
| D-298-2016 | Class II | Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essentia | September 3, 2015 |
| D-309-2016 | Class II | HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N. University, Pe | September 3, 2015 |
| D-336-2016 | Class II | TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4 | September 3, 2015 |
| D-335-2016 | Class II | TRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 | September 3, 2015 |
| D-312-2016 | Class II | LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wel | September 3, 2015 |
| D-299-2016 | Class II | 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Welln | September 3, 2015 |
| D-315-2016 | Class II | Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 mL vials, Rx o | September 3, 2015 |
| D-328-2016 | Class II | Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx | September 3, 2015 |