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 Omega-3 Fatty Acid Capsules, 1000 mg, because they may be mislabeled as other medications. The affected products were distributed in Arizona, California, Oregon, and Washington.
Aidapak Services is recalling Colesevelam HCL tablets that may be mislabeled as lamoTRIgine due to a labeling error.
Aidapak Services is recalling Lubiprostone capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Amantadine HCl 100 mg.
Aidapak Services is recalling methylprednisolone tablets that may be mislabeled as levothyroxine sodium due to a labeling mixup.
Aidapak Services is recalling Zolpidem Tartrate tablets that may be mislabeled as Temazepam capsules due to a label mixup.
Aidapak Services is recalling Sulfasalazine 500 mg tablets because they may be mislabeled as Hyoscyamine Sulfate 0.125 mg.
Aidapak Services is recalling Sertraline HCL 50 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
Aidapak Services, LLC is recalling Atenolol tablets that may be mislabeled as Vitamin B Complex or Piroxicam. The error involves specific pedigree codes and expiration dates.
Aidapak Services, LLC is recalling Modafinil 50 mg tablets that may be mislabeled as Saccharomyces boulardii capsules due to a labeling mixup.
Aidapak Services is recalling HydrALAZINE HCl tablets because they may be mislabeled as other prescription drugs. The recall covers repacked drugs distributed in four western states.
Aidapak Services, LLC is recalling 5,000-unit Cholecalciferol capsules because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
Aidapak Services is recalling Nifedipine 10 mg capsules due to a potential label mixup with multivitamin products.
Aidapak Services is recalling Metoprolol Tartrate 25 mg tablets because they may be mislabeled as Ascorbic Acid or Amlodipine Besylate.
Aidapak Services, LLC is recalling Aripiprazole 15 mg tablets because they may be mislabeled as Atomoxetine or Pramipexole.
Aidapak Services is recalling Fluconazole 100 mg tablets because they may be mislabeled as Prenatal Multivitamin/Multimineral tablets.
Aidapak Services is recalling 1,013 sodium bicarbonate tablets that may be mislabeled as nicotine polacrilex lozenges.
Aidapak Services, LLC is recalling 1 mg Melatonin tablets because they may be mislabeled as other medications. The affected products were distributed in four western states.
Aidapak Services, LLC is recalling Losartan Potassium 25 mg tablets because they may be mislabeled as other medications. The repacked drugs were distributed in four western states.
Aidapak Services is recalling Cilostazol 100 mg tablets due to a labeling mixup where they may be mislabeled as Dutasteride 0.5 mg capsules.
Aidapak Services, LLC is recalling 500 mg Ascorbic Acid tablets that may be mislabeled as Febuxostat 40 mg. The error could lead to incorrect medication administration.
Aidapak Services, LLC is recalling 402 Metoprolol Tartrate tablets because they may be mislabeled as Docusate Sodium capsules.
Aidapak Services is recalling Quetiapine Fumarate tablets that may be mislabeled as Simvastatin. The FDA classifies this as a Class II recall.
Aidapak Services, LLC is recalling prenatal multivitamin tablets that may be mislabeled as other medications like riluzole or aspirin.
Aidapak Services, LLC is recalling Trazodone HCl 50 mg tablets because they may be mislabeled as Dexamethasone, Docusate Sodium, or Guanfacine.