FDA (Drugs) recall action 69674
The FDA (Drugs) publishes a recall like this one as 17 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 17 pages.
Lack of sterility assurance;All lots of sterile products compounded by the pharmacy that are within expiry were recalled due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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.
Perry Drug Inc. is recalling Tri Mix PF SYR 0.5 mL Inj. syringes in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.
Perry Drug Inc. is recalling Cyclosporine 0.045% eye drops due to potential sterility assurance issues identified during an FDA inspection.
Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
Perry Drug Inc. is recalling HCG-20,000 U/2 mL vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling 186 prefilled syringes of Methyl B12 injection due to potential sterility assurance issues identified during an FDA inspection.
Perry Drug Inc. is recalling specific lots of compounded Phenylephrine HCl syringes due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling HCG 200 IU/mL Injection vials in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.
Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling Testosterone Cyp 200 mg/mL syringes due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling HCG Low Dose vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling 17 vials of compounded Tri-Mix in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling 20 vials of compounded Sodium Tetradecyl Sulfate 0.3% Injection in Kansas and Missouri due to potential sterility assurance issues found during an FDA inspection.
Perry Drug Inc. is recalling HCG 10,000 U/10 mL PF Inj vials in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling compounded Testosterone CYP-250/PROP-20 mg syringes in Kansas and Missouri due to quality control issues affecting sterility assurance.
Perry Drug Inc. is recalling HCG injections due to quality control issues that may compromise sterility assurance.
Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.
Perry Drug Inc. is recalling compounded HCG injections in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.