FDA (Drugs) recall action 72241
The FDA (Drugs) publishes a recall like this one as 39 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 39 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Essential Wellness Pharma is recalling Dual Test Cyp/ena Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Essential Wellness Pharma is recalling BIMIX INJ 30 mg-1 mg/mL Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharma is recalling Sermorelin 1000 mcg/mL / LIDO 0.2% Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Essential Wellness Pharma is recalling 17-Alpha Hydroxyprogesterone injections due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling Dexamethasone 0.4% Opth Ointment because poor production practices may have compromised sterility.
Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharma is recalling specific lots of Progesterone 100 mg/mL Ethyl Oleate Injection due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #2 Injection vials because poor sterile production practices resulted in a lack of sterility assurance for the finished drugs.
Essential Wellness Pharma is recalling MIC Injection vials because poor production practices may have compromised the sterility of the finished drugs.
Kalman Health & Wellness is recalling 20 vials of Testosterone Injection due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling HCG 5000 Units/mL injection vials because poor production practices raised concerns about the sterility of the compounded drugs.
FDA is recalling HCG 2000 Units/mL Injection vials from Essential Wellness Pharmacy due to poor sterile production practices.
Essential Wellness Pharma is recalling compounded progesterone injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharma is recalling Testosterone Cypionate 200 mcg/mL injections because poor sterile production practices resulted in a lack of sterility assurance.
Essential Wellness Pharma is recalling Testosterone CYP/ENAN/PROP Injection vials due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #3 Injection vials because poor sterile production practices resulted in a lack of sterility assurance.
Essential Wellness Pharma is recalling 76 vials of LIPO B Injection because poor production practices created a lack of sterility assurance.
Essential Wellness Pharma is recalling QUAD MIX Injection vials because poor sterile production practices may have compromised the sterility of the finished drugs.
Essential Wellness Pharmacy is recalling Methylcobalamin 20 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 25 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling 49 vials of HCG 1000 Units/mL injections nationwide due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling TRIMIX #1 Injection vials because poor production practices may have compromised the sterility of the compounded sterile preparations.
Essential Wellness Pharma is recalling LIPO-B Special Injection vials because poor sterile production practices created a lack of sterility assurance.
Essential Wellness Pharma is recalling HCG 3000 Units/mL Injection vials due to poor sterile production practices that compromised sterility assurance.