FDA (Drugs) recall action 73336
The FDA (Drugs) publishes a recall like this one as 13 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 13 pages.
Lack of Assurance of Sterility
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.
Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution due to a lack of assurance of sterility. The product is distributed in Pennsylvania.
Walter's Pharmacy is recalling Tobramycin 15mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects specific lots distributed in Pennsylvania.
Walter's Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.
Walter's Pharmacy is recalling specific lots of Cefazolin 50 mg/mL Ophthalmic Solution because the sterility of the product cannot be assured.
Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.
Walter's Pharmacy is recalling specific lots of Vancomycin 25mg/mL solution due to a lack of assurance of sterility. The affected products were distributed in Pennsylvania.
Walter's Pharmacy is recalling Lidocaine Nebulizer 1% Solution because the product lacks assurance of sterility. The recall affects five bottles distributed in Pennsylvania.
Walter's Pharmacy is recalling 3 bottles of Edetate Disodium 3% Ophth Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.
Walter's Pharmacy is recalling Lidocaine Nebulizer 2% Solution because the product lacks assurance of sterility. The recall affects 5 bottles distributed in Pennsylvania.
Walter's Pharmacy is recalling Vancomycin 50mg/mL Solution because there is a lack of assurance of sterility. The recall affects 10mL bottles distributed in Pennsylvania.
Walter's Pharmacy is recalling Tobramycin 14 mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects 10 mL bottles distributed in Pennsylvania.
Walter's Pharmacy is recalling three bottles of Rose Bengal 1% Ophthalmic Solution because the agency could not ensure the product was sterile.
Walter's Pharmacy is recalling 22 bottles of Atropine 0.01% Ophthalmic Solution in Pennsylvania due to a lack of assurance of sterility.