FDA (Drugs) recall action 69184
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
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.
Pharmacy Creations is recalling 12 vials of Glutathione 100mg/mL Sterile Injection due to failing sterility test results.
Pharmacy Creations is recalling 67 vials of Ascorbic Acid 500 mg/mL Sterile Injection because contract testing indicated the product may not be sterile.
Pharmacy Creations is recalling 50 bottles of Tropi/Cyclo/Phenyl/Tobra/Flurb sterile ophthalmic solution due to failing sterility test results.
Pharmacy Creations is recalling 52 vials of Magnesium Chloride 20% Injection because contract testing indicated the product may not be sterile.