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 TRIMIX SPECIAL Injection vials because poor sterile production practices created a lack of sterility assurance for the finished drugs.
Essential Wellness Pharmacy is recalling Methylcobalamin 30 mg/mL prefilled syringes due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharmacy is recalling Progesterone 100 mg/mL injections due to poor sterile production practices that compromised sterility assurance.
Kalman Health & Wellness is recalling Glycerin Opth Solution because poor sterile production practices may have compromised the sterility of the finished drug.
Kalman Health & Wellness is recalling TRIMIX #4 Injection vials due to poor sterile production practices that compromise sterility assurance.
Kalman Health & Wellness is recalling Sermorelin injections due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling specific lots of Cyclosporin 0.1% Opth Solution because poor sterile production practices created a lack of sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 5000 mcg/mL injections due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling Testosterone Cypionate 50 mg/mL injections due to poor sterile production practices that compromise sterility assurance.
Essential Wellness Pharma is recalling 261 vials of Testosterone Cypionate 200 mcg/mL injection because poor sterile production practices resulted in a lack of sterility assurance.
Kalman Health & Wellness is recalling HCG 1000 U/LIDO 0.2% Injection vials due to poor sterile production practices that compromised sterility assurance.
Kalman Health & Wellness is recalling HCG 10,000 Units/mL injections because poor sterile production practices created a lack of sterility assurance.
Essential Wellness Pharma is recalling Acetylcysteine 10% Ophthalmic Solution due to poor sterile production practices that compromised sterility assurance.
Essential Wellness Pharmacy is recalling Methylcobalamin 1 mg/mL prefilled syringes due to poor sterile production practices that compromised sterility assurance.