Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose.
1,411 FDA drug recalls with this cause, newest first.
This is exactly what it sounds like: the wrong label on the right product, the wrong strength printed on the bottle, a missing or illegible lot number and expiry date, or two products mixed up during packaging. It is dangerous precisely because the pill or liquid itself may be fine, yet the patient has no way of knowing what they are actually taking. A high share of the Class I recalls in this group are mix-ups where a stronger product ended up in a weaker product's packaging.
Labeling: Label Mixup; CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00536406001, Pedigree: W002653, EXP: 6/5/2014; MODAFINIL, Tablet, 200 mg, NDC 00603466216, Pedigree: W003779, EXP: 6/26/2014; NIACIN ER, Tablet, 500 mg, NDC 00074307490, Pedigree: W003739, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN, Capsule, 500 mg/40
Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4, EXP: 5/10/2014.
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC 00904506260, Pedigree: AD21846_24, EXP: 5/1/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: AD60240_4, EXP: 5/22/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: W003020, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, ND
Labeling: Label Mixup; PHYTONADIONE Tablet, 5 mg may be potentially mislabeled as medroxyPROGESTERone ACETATE, Tablet, 10 mg, NDC 59762374202, Pedigree: AD46312_19, EXP: 5/16/2014; HYDROCORTISONE, Tablet, 5 mg, NDC 00603389919, Pedigree: W003060, EXP: 6/12/2014; GALANTAMINE HBR ER, Capsule, 24 mg, NDC 47335083783, Pedigree: W003735, EXP: 5/31/2014; TORSEMIDE, Tablet, 10 mg, NDC 31722053001,
Labeling: Label Mixup; NICOTINE POLACRILEX Gum, 2 mg may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD54586_4, EXP: 5/21/2014.
Labeling: Label Mixup; LACTASE ENZYME Tablet, 3000 units may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/3.6 mg, NDC 63824072016, Pedigree: AD21811_4, EXP: 5/1/2014; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, NDC 46122010478, Pedigree: W003722, EXP: 4/30/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: AD30140_37, EXP: 5/7/2014; CALCIUM
Labeling: Label Mixup; ERYTHROMYCIN DR EC Tablet, 250 mg may be potentially mislabeled as methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD46426_10, EXP: 5/15/2014.
Labeling: Label Mixup; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN Capsule may be potentially mislabeled as CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD21846_37, EXP: 5/1/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: AD60240_42, EXP: 5/22/2014; CAFFEINE, Tablet, 200 mg, NDC 24385060173, Pedigree: W003024, EXP: 6/12/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: AD73
Labeling: Label Mixup; VENLAFAXINE HCL Tablet, 50 mg may be potentially mislabeled as sulfaSALAzine, Tablet, 500 mg, NDC 00603580121, Pedigree: AD65475_19, EXP: 5/28/2014.
Labeling: Label Mixup; ACARBOSE Tablet, 25 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD39588_4, EXP: 5/13/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS, Capsule, NDC 54629011101, Pedigree: AD65311_4, EXP: 5/24/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.
Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC
Labeling: Label Mixup; metFORMIN HCl Tablet, 500 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: AD32742_1, EXP: 5/1/2014.
Labeling: Label Mixup; LEFLUNOMIDE Tablet, 10 mg may be potentially mislabeled as DOXYCYCLINE HYCLATE, Capsule, 100 mg, NDC 00143314250, Pedigree: W002645, EXP: 6/5/2014; SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002623, EXP: 6/4/2014.
Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.
Labeling: Label Mixup; HYDROCHLOROTHIAZIDE Tablet, 12.5 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD46333_4, EXP: 5/16/2014.
Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, EXP: 6/24/2014.
Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet,
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: W003117, EXP: 6/13/2014.
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.
Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD68028_1, EXP: 5/28/2014; METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003844, EXP: 6/27/2014; LACTOBACILLUS ACIDOPHILUS, Tablet, 35 Million, NDC 00536718101, Pedigree: W003865, EXP: 6/27/2014; OXYBUTYNIN CHLORIDE, Tablet,
Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP: 5/23/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003061, EXP: 5/31/2014.
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