FDA (Drugs) recall action 90553
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.
CGMP Deviations: products were stored outside the drug label specifications.
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.
McKesson Medical-Surgical is recalling Bisacodyl suppositories stored outside label specifications. The FDA Class II recall affects 45 boxes distributed nationwide.
The FDA recalled 67 bottles of Miralax laxative powder due to storage conditions that violated drug label specifications. The precautionary recall is due to potential product quality concerns from improper storage conditions.
GenTeal eye ointment (40 boxes, nationwide) recalled due to CGMP storage deviations. Products were stored outside drug label specifications.
Asthmanefrin Racephinephrine Inhalation Solution is being recalled because batches were stored outside the conditions specified on the drug label. The recall affects products distributed nationwide.
McKesson Medical-Surgical recalled 113 bottles of Dakin's Solution (sodium hypochlorite) nationwide due to improper storage outside label specifications. Products may have compromised stability.
Mckesson Medical-Surgical has recalled Eye-stream eye wash solution nationwide due to storage conditions outside drug label specifications.
McKesson Medical-Surgical Inc. is recalling Triple Antibiotic Ointment due to storage deviations that violated drug label specifications and current good manufacturing practices.
McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.
SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.
Debrox earwax removal aid is recalled nationwide because 131 boxes of the product were stored outside label-specified conditions. Consumers should discontinue use and consult a healthcare provider if needed.
A&D Original Ointment 16 oz jars are being recalled nationwide because products were stored outside manufacturer specifications. The recall affects all NDC 11523-0096-3 units distributed in the USA.
Mckesson Medical-Surgical is recalling ALCOHOL PREP sterile alcohol prep pads nationwide because they were stored outside manufacturer specifications, potentially compromising sterility. FDA classified this as a Class II recall.
ZADITOR eye drops were stored outside FDA label specifications in a nationwide Class II recall affecting 9 boxes distributed by McKesson Medical-Surgical Inc.
Mckesson Medical-Surgical is recalling Pataday Once Daily Relief eye drops nationwide because the products were stored outside label specifications. No illnesses have been reported.
Mckesson Medical-Surgical is recalling S2 Racepinephrine Inhalation Solution due to storage that deviated from label specifications. This Class II recall affects 23 cartons distributed nationwide.
McKesson is recalling Dynarex Alcohol Swabsticks nationwide because products were stored outside the conditions specified on the drug label.
Naphcon A eye drops are being recalled nationwide because products were stored outside label specifications, violating Current Good Manufacturing Practice (CGMP) standards.