Novartis Consumer Health Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL recall — FDA D-744-2014
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Complete FDA and NHTSA recall records dated in 2014, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Labeling: Label Mixup; RILUZOLE Tablet, 50 mg may be potentially mislabeled as traZODone HCl, Tablet, 150 mg, NDC 50111044101, Pedigree: W003245, EXP: 6/17/2014.
Labeling: Label Mixup; MELATONIN Tablet, 3 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD25452_13, EXP: 5/3/2014; PIOGLITAZONE, Tablet,…
Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD73525_52, EXP:…
Labeling: Label Mixup; LACTOBACILLUS Tablet may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: AD62979_1, EXP: 5/23/2014; CALCIUM ACETATE,…
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same…
Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR,…
Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg, NDC 53746019001, Pedigree: AD68025_8, EXP:…
Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1,…
Labeling: Label Mixup; aMILoride HCl Tablet, 5 mg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD60272_37, EXP: 5/22/2014; FAMOTIDINE, Tablet,…
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013;…
Labeling: Label Mixup; TORSEMIDE Tablet, 10 mg may be potentially mislabeled as MEXILETINE HCL, Capsule, 200 mg, NDC 00093874001, Pedigree: AD25264_7, EXP: 5/3/2014.
Labeling:Label Mixup; MISOPROSTOL Tablet, 200 mcg may be potentially mislabeled as PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: AD21790_34, EXP: 5/1/2014; SODIUM CHLORIDE,…
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same…
Labeling:Label Mixup; GLIMEPIRIDE, Tablet, 1 mg may be potentially mislabeled as clomiPRAMINE HCl, Capsule, 50 mg, NDC 51672401205, Pedigree: AD73525_4, EXP: 5/30/2014.
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same…
Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE…
Labeling:Label Mixup; IRBESARTAN, Tablet, 150 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: W003597, EXP:…
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same…
Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.
Labeling: Label Mixup; OMEGA-3 FATTY ACID, Capsule, 1000 mg may be potentially mis-labeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: AD33897_16, EXP: 5/9/2014;…
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same…
Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine…
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.