FDA (Drugs) recall action 80633
The FDA (Drugs) publishes a recall like this one as 15 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 15 pages.
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to 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.
Ranier's Compounding Laboratory is recalling Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.
Ranier's Compounding Laboratory is recalling DMSO 6.25% Opth Sol due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
Ranier's Compounding Laboratory is recalling Vitamin D3 Injection, 50,000 IU/mL, 4 mL vials, because practices at the firm may call into question the sterility of the product.
Ranier's Compounding Laboratory is recalling Atropine 0.01% Opth Solution due to a lack of assurance of sterility. The product was distributed within Pennsylvania.
Ranier's Compounding Laboratory is recalling Triple P Injection due to practices that may call into question the sterility of the product.
Ranier's Compounding Laboratory is recalling PR/PA/PH Injection vials due to a lack of assurance of sterility. The product was distributed in Pennsylvania.
Ranier's Compounding Laboratory is recalling 60 vials of Morphine Sulf inhalation because practices at the firm may call into question the sterility of the product.
Ranier's Compounding Laboratory is recalling Papav 300/Phent 5mg/10mL Injection due to lack of assurance of sterility. The product was distributed in Pennsylvania.
Ranier's Compounding Laboratory is recalling Medroxprogesterone 1% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.
Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the product.
Ranier's Compounding Laboratory is recalling Dehydrated Alcohol Solution vials because practices at the firm may call into question the sterility of the products.
Ranier's Compounding Laboratory is recalling P/P/P Injection vials because practices at the firm may call into question the sterility of the products.
Ranier's Compounding Laboratory is recalling 213 Avastin prefilled syringes because practices at the firm may call into question the sterility of the products.
Ranier's Compounding Laboratory is recalling PRASH Injection vials because practices at the firm may call into question the sterility of the product.
Ranier's Compounding Laboratory is recalling Pro/PA/PH/AT Injection in Pennsylvania due to a lack of assurance of sterility.