FDA (Drugs) recall action 66083
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Lack of Assurance of Sterility: Park Compounding is voluntarily recalling two lots of Methylcobalamin 5mg/ml and Multitrace-5 Concentrate, and one lot of Testosterone Cypionate (sesame oil) for injection due lack of sterility assurance.
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.
South Coast Specialty Compounding is recalling Methylcobalamin Injection 5 mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in California and Indiana.
South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.
Park Compounding is recalling Methylcobalamin, Multitrace-5, and Testosterone Cypionate injections due to lack of sterility assurance.