Class II · Moderate risk
ZONISAMIDE Capsule
Labeling: Label Mixup; ZONISAMIDE Capsule, 100 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003737, EXP: 5/31/2014.
Labeling errors & mix-ups
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.
Class II · Moderate risk
LISINOPRIL Tablet
Labeling: Label Mixup; LISINOPRIL Tablet, 2.5 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: AD23087_1, EXP: 5/2/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003358, EXP: 6/19/2014.
Class II · Moderate risk
Zolpidem Tartrate
Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 40 mg may be potentially mislabeled as SENNOSIDES, Tablet, 8.6 mg, NDC 60258095001, Pedigree: AD37063_17, EXP: 5/13/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR Tablet, 20 mg may be potentially mislabeled as FOSINOPRIL SODIUM, Tablet, 20 mg, NDC 60505251102, Pedigree: AD70690_1, EXP: 5/29/2014.
Class II · Moderate risk
MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet
Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL LOW IRON Tablet may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00527134601, Pedigree: AD60272_22, EXP: 5/22/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD73627_1, EXP: 5/30/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: W002513, EXP: 6/3/2014.
Class II · Moderate risk
Multivitamin/Multimineral W/Fluoride
Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F) may be potentially mislabeled as ISOMETHEPTENE MUCATE/ DICHLORALPHENAZONE/APAP, Capsule, 65 mg/100 mg/325 mg, NDC 44183044001, Pedigree: AD22858_1, EXP: 3/31/2014.
Class II · Moderate risk
Benzocaine/Menthol
Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.
Class II · Moderate risk
BENZOCAINE/MENTHOL Lozenge
Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060, Pedigree: AD21811_1, EXP: 5/1/2014; LOSARTAN POTASSIUM, Tablet, 50 mg, NDC 00093736598, Pedigree: W003268, EXP: 6/17/2014.
Class II · Moderate risk
guaiFENesin ER Tablet
Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.
Class II · Moderate risk
guaiFENesin ER Tablet
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg,
Class II · Moderate risk
guaiFENesin ER
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
Class II · Moderate risk
Lurasidone HCL
Labeling:Label Mixup; LURASIDONE HCl Tablet, 120 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003486, EXP: 6/20/2014.
Class II · Moderate risk
Eszopiclone
Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.
Class II · Moderate risk
ATENOLOL Tablet
Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014; PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014.
Class II · Moderate risk
METOPROLOL TARTRATE Tablet
Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as PIOGLITAZONE, Tablet, 15 mg, NDC 00591320530, Pedigree: AD22845_1, EXP: 4/30/2014; LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD73525_49, EXP: 5/30/2014.
Class II · Moderate risk
HYDROXYCHLOROQUINE SULFATE Tablet
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.
Class II · Moderate risk
CALCITRIOL Capsule
Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.
Class II · Moderate risk
LETROZOLE Tablet
Labeling:Label Mixup; LETROZOLE Tablet, 2.5 mg may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 50 mg, NDC 00093073301, Pedigree: W003848, EXP: 6/27/2014.
Class II · Moderate risk
OXcarbazepine Tablet
Labeling:Label Mixup; OXcarbazepine Tablet, 600 mg may be potentially mislabeled as LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: AD30028_25, EXP: 5/7/2014.
Class II · Moderate risk
OXcarbazepine Tablet
Labeling:Label Mixup; OXcarbazepine Tablet, 150 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD54562_1, EXP: 5/20/2014.
Class II · Moderate risk
PANTOPRAZOLE SODIUM DR Tablet
Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.
Class II · Moderate risk
ISOSORBIDE MONONITRATE ER Tablet
Labeling:Label Mixup; ISOSORBIDE MONONITRATE ER Tablet, 30 mg may be potentially mislabeled as LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003899, EXP: 6/27/2014; MISOPROSTOL, Tablet, 100 mcg, NDC 43386016012, Pedigree: AD42611_7, EXP: 5/14/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003332, EXP: 6/18/2014; glyBURIDE, Tablet, 2.5 mg, NDC 0009383
Class II · Moderate risk
Isosorbide Mononitrate
Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 20 mg may be potentially mislabeled as COLCHICINE, Tablet, 0.6 mg, NDC 64764011907, Pedigree: AD52778_22, EXP: 5/20/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: AD67989_7, EXP: 5/28/2014; SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: W002611, EXP: 6/4/2014.
Class II · Moderate risk
ISOSORBIDE MONONITRATE Tablet
Labeling:Label Mixup; ISOSORBIDE MONONITRATE Tablet, 10 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD28322_10, EXP: 5/6/2014.
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