Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalls
FDA enforcement reports naming Kalman Health & Wellness, Inc. dba Essential Wellness Pharma as the recalling firm.
- Recall reports
- 39
- Class I (serious)
- 0
- Most recent report
- Nov 25, 2015
- Nov 25, 2015Cyclosporin 0Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015Dexamethasone 0Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx…Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015Glycerin Opth Solution, 10 mL dropper bottles, Rx only, Essential Wellness PHARMACY, 46…Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015HCG 1000 U/ LIDO 0Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015HCG 2000 Units/mL Injection, packaged in a) 4 mL and b) 15 mL vials, Rx only, Essential…Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015HCG 5000 Units/mL Injection, 0Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only,…Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015Methylcobalamin 5000 mcg/mL Preservative Free Injection, packaged in a) 4 mL and b) 8 m…Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Nov 25, 2015Methylcobalamin 20 mg/mL PF Injection, 0Drug · Kalman Health & Wellness, Inc. dba Essential Wellness PharmaLack 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 as…Class II
- Methylcobalamin 25 mg/mL PF Injection, 0
- MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N
- Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wel…
- Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness P…
- Progesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness…
- QUAD MIX (30 mg-1 mg-20 mcg-0
- Sermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7
- sermorelin 1000 mcg/mL / LIDO 0
- Testosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHAR…
- Testosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100…
- Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential…
- Testosterone CYP/ENAN/PROP Injection, 66
- Testosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66
- TRIMIX #2 (24 mg-0
- TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHA…
- TRIMIX #4 (27 mg-1
- HCG 1000 Units/mL SUB-Q Injection, packaged in a)1
- HCG 3000 Units/mL Injection, 2 mL vial, Rx only, Essential Wellness PHARMACY, 4625 N
- HCG 10,000 Units/mL Injection, packaged in a) 1 mL, b) 1
- LIPO-B Special Injection,12 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N
- Methylcobalamin 1 mg/mL (Pres Free) Injection, 1 mL prefilled syringes, Rx only, Essent…
- Methylcobalamin 30 mg/mL PF Injection, 0
- TRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellnes…
- 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Es…
- 17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection, 5 mL vials, Rx only, Es…
- BIMIX INJ 30 mg-1 mg/mL Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 46…
- Sermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9…
- TRIMIX #1 Injection, 4
- Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx o…
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