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: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014.
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as the following drug: guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: W003007, EXP: 6/12/2014.
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg) may have potentially been mislabeled as one of the following drugs: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD30180_1, EXP: 5/8/2014; carBAMazepine ER, Capsule, 200 mg, NDC 66993040832, Pedigree: AD32764_14, EXP: 5/14/2014; CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 00378022201, Pedigree:
Labeling: Label Mixup: DIGOXIN, Tablet, 125 mcg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: W002581, EXP: 6/3/2014.
Labeling: Label Mixup: SODIUM CHLORIDE, Tablet, 1000 mg may have potentially been mislabeled as the following drug: REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: W003925, EXP: 7/1/2014.
Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabeled as the following drug: predniSONE, Tablet, 20 mg, NDC 00591544301, Pedigree: AD56879_5, EXP: 5/21/2014.
Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabeled as the following drug: predniSONE, Tablet, 20 mg, NDC 00591544301, Pedigree: AD56879_5, EXP: 5/21/2014.
Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: AD73611_1, EXP: 5/30/2014; RASAGILINE MESYLATE, Tablet, 0.5 mg, NDC 68546014256, Pedigree: W002929, EXP: 6/10/2014.
Labeling: Label Mixup: THYROID, Tablet, 60 mg may have potentially been mislabeled as the following drug: THYROID, Tablet, 30 mg, NDC 00456045801, Pedigree: W002847, EXP: 6/7/2014.
Labeling: Label Mixup: THYROID, Tablet, 30 mg may have potentially been mislabeled as one of the following drugs: OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, NDC 11523726503, Pedigree: AD70655_20, EXP: 5/29/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 37205098769, Pedigree: AD73623_7, EXP: 5/30/2014; PYRIDOXINE HCL, Tablet, 50 mg, NDC 51645090901, Pedigree: W002697, EXP: 6/5/2014.
Labeling: Label Mixup: MESALAMINE DR, Capsule, 400 mg may have potentially been mislabeled as the following drug: CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, NDC 11868000901, Pedigree: AD34928_1, EXP: 5/9/2014.
Labeling: Label Mixup: SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD21787_1, EXP: 5/1/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 76439030910, Pedigree: AD54501_1, EXP: 5/21/2014; VARENICLINE, Tablet, 0.5 mg, NDC 00069046856, Pedigree: W003083, EXP: 6/12/2014; L
Labeling: Label Mixup: FLUVASTATIN, Capsule, 20 mg may have potentially been mislabeled as the following drug: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, NDC 00603254421, Pedigree: W002654, EXP: 6/4/2014.
Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG, NDC 64764024060, Pedigree: AD21790_46, EXP: 5/1/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: AD60272_55, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W002732, EXP: 6/6/2014.
Labeling: Label Mixup: VERAPAMIL HCL ER, Capsule, 240 mg may have potentially been mislabeled as the following drug: FEBUXOSTAT, Tablet, 40 mg, NDC 64764091830, Pedigree: W002664, EXP: 6/5/2014.
Labeling: Label Mixup: ALBUTEROL SULFATE ER, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: SIMVASTATIN, Tablet, 20 mg, NDC 16714068303, Pedigree: W003580, EXP: 6/24/2014.
Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.
Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, NDC 00904506260, Pedigree: AD28333_1, EXP: 5/8/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD49414_7, EXP: 5/17/2014.
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg, NDC 16714058501, Pedigree: W003761, EXP: 6/26/2014.
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 11845014882, Pedigree: AD70700_7, EXP: 5/29/2014; TACROLIMUS, Capsule, 0.5 mg, NDC 00781210201, Pedigree: W003169, EXP: 6/13/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: AD42584_1, EXP: 5/14/2014.
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 40 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD33897_4, EXP: 5/9/2014; FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: W003031, EXP: 2/28/2014.
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 20 mg may have potentially been mislabeled as one of the following drugs: COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD32325_4, EXP: 5/9/2014; ATORVASTATIN CALCIUM, Tablet, 10 mg, NDC 00378201577, Pedigree: AD49582_7, EXP: 5/16/2014.
Labeling: Label Mixup: ATORVASTATIN CALCIUM, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: PANCRELIPASE DR, Capsule, 12000 /38000 /60000 USP units, NDC 00032121201, Pedigree: AD30180_4, EXP: 5/8/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD49399_4, EXP: 5/16/2014; ASPIRIN, CHEW Tablet, 81 mg, NDC 00536329736, Pedi
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 1 mg, NDC 16714058701, Pedigree: W003150, EXP: 6/13/2014.
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as one of the following drugs: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), NDC 00904533260, Pedigree: AD57624_1, EXP: 5/9/2014; hydrALAZINE HCl, Tablet, 50 mg, NDC 50111032801, Pedigree: AD52778_28, EXP: 5/20/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003828, EXP: 6/
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