Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Drugs Recalls
Prescription and over-the-counter medications
Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05.
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
HYDROCORTISONE 1% 30gm cream
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432
Cardinal Health
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.