FDA (Drugs) recall action 65707
The FDA (Drugs) publishes a recall like this one as 273 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 273 pages.
Labeling: Label Mixup; NIACIN TR, Tablet, 500 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W002968, EXP: 6/11/2014.
Labeling: Label Mixup; HYOSCYAMINE SULFATE ER Tablet, 0.375 mg may be potentially mislabeled as SERTRALINE HCL, Tablet, 50 mg, NDC 16714061204, Pedigree: W003575, EXP: 6/24/2014.
Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.
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.
Aidapak Services, LLC is recalling Niacin TR tablets because they may be mislabeled as Lactobacillus GG capsules.
Aidapak Services, LLC is recalling Hyoscyamine Sulfate ER tablets because they may be mislabeled as Sertraline HCL. The error involves a label mixup.
Aidapak Services, LLC is recalling buPROPion HCl ER 200 mg tablets because they may be mislabeled as amantadine HCl 100 mg capsules.
Aidapak Services is recalling Metoprolol Tartrate tablets because they may be mislabeled as Pioglitazone or Levothyroxine Sodium.
Aidapak Services is recalling Lurasidone HCl 120 mg tablets because they may be mislabeled as Duloxetine HCl DR 20 mg capsules.
Aidapak Services, LLC is recalling Phytonadione 5 mg tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.
Aidapak Services, LLC is recalling Tizanidine HCL tablets because they may be mislabeled as Nicotine Polacrilex or Nifedipine ER.
Aidapak Services, LLC is recalling 1,821 tablets of Cyanocobalamin 1000 mcg due to a potential label mixup with other medications.
Aidapak Services, LLC is recalling 10 mg Citalopram tablets because they may be mislabeled as Oxybutynin Chloride or Coenzyme Q-10.
Aidapak Services is recalling Flecaïnide Acetate tablets that may be mislabeled as Vitamin B Complex with C due to a labeling error.
Aidapak Services, LLC is recalling specific lots of Colchicine 0.6 mg tablets because they may be mislabeled as other medications.
Aidapak Services is recalling Zinc Sulfate capsules that may be mislabeled as Sertraline HCL tablets. The error could lead to patients taking the wrong medication.
Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Misoprostol. The error could lead to patients receiving the wrong medication.
Aidapak Services is recalling diphenhydramine HCl tablets because they may be mislabeled as atorvastatin, prenatal vitamins, or venlafaxine.
Aidapak Services, LLC is recalling guaiFENesin ER tablets because they may be mislabeled as fenofibrate or glyburide. The error poses a risk of patients taking the wrong medication.
Aidapak Services is recalling Loratadine 10 mg tablets because they may be mislabeled as Glycopyrrolate or Omega-3 fatty acids.
Aidapak Services is recalling Promethazine HCL tablets that may be mislabeled as Cholecalciferol due to a labeling mixup.
Aidapak Services is recalling 250 mg Phosphorus tablets because they may be mislabeled as other prescription drugs. The repacked drugs were distributed in four western states.
Aidapak Services is recalling Febuxostat 40 mg tablets that may be mislabeled as other medications due to a labeling error.
Aidapak Services, LLC is recalling Disulfiram 250 mg tablets because they may be mislabeled as Pyridoxine HCl 50 mg.
Aidapak Services, LLC is recalling Atorvastatin Calcium 80 mg tablets because they may be mislabeled as Lactobacillus GG capsules.
Aidapak Services is recalling Galantamine HBR ER capsules due to a potential label mixup with Escitalopram tablets.
Aidapak Services, LLC is recalling 2,399 tablets of Cholecalciferol 1000 units because they may be mislabeled as other medications.
Aidapak Services, LLC is recalling Pramipexole Di-HCl tablets that may be mislabeled as Liothyronine Sodium. The error poses a risk of incorrect medication administration.
Aidapak Services, LLC is recalling Mirtazapine 7.5 mg tablets because they may be mislabeled as other prescription medications.