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Novartis Consumer Health

FDA Regulatory Profile

Summary

Total Recalls
60
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
F-1591-2014Class IIBenefiber fiber supplement stick packs, sugar free and taste free, packaged in the following configuDecember 18, 2013
D-022-2014Class IIILoratadine, USP 10 mg, Antihistamine, packaged in blister packs. All manufactured by Novartis ConsuSeptember 3, 2013
F-1904-2013Class IIIBenefiber, Fiber Supplement, Orange Creme Chewables, Sugar Free, 36ct and 100ct chewable tablet bottAugust 6, 2013
D-909-2013Class IIIMaalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablAugust 6, 2013
D-910-2013Class IIIMaalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablAugust 6, 2013
F-1903-2013Class IIIBenefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets boAugust 6, 2013
F-1906-2013Class IIIBenefiber, Fiber Supplement, Assorted Fruit, Sugar Free, 100ct chewable tablets. Novartis Consumer HAugust 6, 2013
D-903-2013Class IIIMaalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, pacAugust 6, 2013
D-902-2013Class IIIMaalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 10August 6, 2013
D-908-2013Class IIIMaalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 60August 6, 2013
F-1905-2013Class IIIBenefiber, Fiber Supplement, 72ct and 114 caplet bottles. Novartis Consumer Health, Inc, Parsippany,August 6, 2013
F-1907-2013Class IIIBenefibre, Orange Creme Chewables, 36ct and 100ct chewable tablet bottles. Foreign labeling: NovartAugust 6, 2013
D-905-2013Class IIIMaalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablAugust 6, 2013
D-904-2013Class IIIMaalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablAugust 6, 2013
D-907-2013Class IIIMaalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 5August 6, 2013
D-906-2013Class IIIMaalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaAugust 6, 2013
D-762-2014Class IITheraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramJune 18, 2013
D-763-2014Class IITheraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleaJune 18, 2013
D-754-2014Class IITheraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloriJune 18, 2013
D-751-2014Class IITheraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powderJune 18, 2013