Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-666-2014 | 07-02-2013 | ESTERIFIED ESTROGENS Tablet, 0.625 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61570007301 | Labeling:Label Mixup; ESTERIFIED ESTROGENS, Tablet, 0.625 mg may be potentially mislabeled as ETODOLAC, Tablet, 400 mg, NDC 51672401801, Pedigree: W003734, EXP: 6/26/2014. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-595-2014 | 07-02-2013 | TORSEMIDE Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111091601 | Labeling: Label Mixup; TORSEMIDE, Tablet, 10 mg may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00536440801, Pedigree: AD30197_22, EXP: 5/9/2014. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-502-2014 | 07-02-2013 | OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD46300_11, EXP: 5/15/2014; MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00781206701, Pedigree: AD65457_7, EXP: 5/24/2014. | Aidapak Services, LLC / 294 Capsules | Class II | Terminated |
| D-485-2014 | 07-02-2013 | CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360 | Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053 | Aidapak Services, LLC / 1,199 Tablets | Class II | Terminated |
| D-685-2014 | 07-02-2013 | BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824072016 | 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. | Aidapak Services, LLC / 80 Lozenges | Class II | Terminated |
| D-525-2014 | 07-02-2013 | HYDROCHLOROTHIAZIDE Tablet, 12.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16729018201 | 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. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-530-2014 | 07-02-2013 | PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 23155011001 | 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. | Aidapak Services, LLC / 198 Tablets | Class II | Terminated |
| D-619-2014 | 07-02-2013 | OLANZapine Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55111016530 | Labeling:Label Mixup; OLANZapine, Tablet, 7.5 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00527135001, Pedigree: AD46265_37, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD60272_73, EXP: 5/22/2014; MIRTAZAPINE, Tablet, 7.5 mg, NDC 59762141503, Pedigree: AD73525_55, EXP: 5/30/2014. | Aidapak Services, LLC / 210 Tablets | Class II | Terminated |
| D-629-2014 | 07-02-2013 | METOPROLOL TARTRATE Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050652 | Labeling:Label Mixup; METOPROLOL TARTRATE, Tablet, 25 mg may be potentially mislabeled as ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: W003826, EXP: 6/27/2014; amLODIPine BESYLATE, Tablet, 5 mg, NDC 00093716798, Pedigree: W002840, EXP: 6/7/2014. | Aidapak Services, LLC / 300 Tablets | Class II | Terminated |
| D-720-2014 | 07-02-2013 | SELEGILINE HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67253070006 | Labeling:Label Mixup; SELEGILINE HCL, Capsule, 5 mg may be potentially mislabeled as ITRACONAZOLE, Capsule, 100 mg, NDC 10147170003, Pedigree: AD54549_10, EXP: 5/20/2014. | Aidapak Services, LLC / 60 Capsules | Class II | Terminated |
| D-506-2014 | 07-02-2013 | CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 11868000901 | Labeling: Label Mixup; CHLOROPHYLLIN COPPER COMPLEX, Tablet, 100 mg may be potentially mislabeled as traZODone HCl, Tablet, 50 mg, NDC 50111043301, Pedigree: AD37088_4, EXP: 5/9/2014. | Aidapak Services, LLC / 135 Tablets | Class II | Terminated |
| D-503-2014 | 07-02-2013 | OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 11523726503 | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: AD42592_4, EXP: 5/14/2014. | Aidapak Services, LLC / 84 Capsules | Class II | Terminated |
| D-484-2014 | 07-02-2013 | GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904559293 | Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Tablet, 500 mg/400 mg may be potentially mislabeled as DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD60211_11, EXP: 5/22/2014. | Aidapak Services, LLC / 180 Tablets | Class II | Terminated |
| D-543-2014 | 07-02-2013 | CRANBERRY EXTRACT/VITAMIN C Capsule, 450 mg/125 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 31604014271 | 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 | Aidapak Services, LLC / 546 Capsules | Class II | Terminated |
| D-679-2014 | 07-02-2013 | ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101 | 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. | Aidapak Services, LLC / 398 Tablets | Class II | Terminated |
| D-659-2014 | 07-02-2013 | CILOSTAZOL Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505252201 | Labeling:Label Mixup; CILOSTAZOL Tablet, 100 mg may be potentially mislabeled as DUTASTERIDE, Capsule, 0.5 mg, NDC 00173071204, Pedigree: AD65475_1, EXP: 5/28/2014. | Aidapak Services, LLC / 60 Tablets | Class II | Terminated |
| D-691-2014 | 07-02-2013 | ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401 | 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. | Aidapak Services, LLC / 402 Tablets | Class II | Terminated |
| D-627-2014 | 07-02-2013 | tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289 | Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, EXP: 6/26/2014. | Aidapak Services, LLC / 299 Tablets | Class II | Terminated |
| D-680-2014 | 07-02-2013 | ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310 | Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-672-2014 | 07-02-2013 | PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046 | 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. | Aidapak Services, LLC / 90 Tablets | Class II | Terminated |
| D-694-2014 | 07-02-2013 | METAXALONE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720032110 | Labeling: Label Mixup; METAXALONE Tablet, 800 mg may be potentially mislabeled as ESTERIFIED ESTROGENS, Tablet, 0.625 mg, NDC 61570007301, Pedigree: W003736, EXP: 6/26/2014. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-667-2014 | 07-02-2013 | RANOLAZINE ER Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 61958100301 | Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: | Aidapak Services, LLC / 840 Tablets | Class II | Terminated |
| D-709-2014 | 07-02-2013 | MULTIVITAMIN/MULTIMINERAL Tablet, Distributed by: AidaPak Service, LLC, NDC 65162066810 | Labeling:Label Mixup; MULTIVITAMIN/MULTIMINERAL Tablet may be potentially mislabeled as PRENATAL MULTIVITAMIN/MULTIMINERAL Tablet, NDC 00904531360, Pedigree: AD73652_16, EXP: 5/30/2014. | Aidapak Services, LLC / 200 Tablets | Class II | Terminated |
| D-481-2014 | 07-02-2013 | GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904548152 | Labeling: Label Mixup; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 mg may be potentially mislabeled as GLYCOPYRROLATE, Tablet, 2 mg, NDC 00603318121, Pedigree: AD22865_4, EXP: 5/2/2014; PREGABALIN, Capsule, 25 mg, NDC 00071101268, Pedigree: W003121, EXP: 6/13/2014; MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 00536344308, Pedigree: AD73521_10, EXP: 5/30/2014. | Aidapak Services, LLC / 180 Capsules | Class II | Terminated |
| D-497-2014 | 07-02-2013 | MELATONIN, Tablet, 3 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 08770140813 | Labeling: Label Mixup; MELATONIN, Tablet, 3 mg may be potentially mislabeled as VITAMIN B COMPLEX, Capsule, NDC 00536478701, Pedigree: AD32757_4, EXP: 5/13/2014; MULTIVITAMIN/ MULTIMINERAL/ LUTEIN, Capsule, NDC 24208063210, Pedigree: W003025, EXP: 6/12/2014; LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree: W003721, EXP: 6/26/2014; GLUCOSAMINE/CHONDROITIN DS, Capsule, 500 mg/400 | Aidapak Services, LLC / 3,710 Tablets | Class II | Terminated |
| D-563-2014 | 07-02-2013 | METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028 | Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014. | Aidapak Services, LLC / 112 Tablets | Class II | Terminated |
| D-565-2014 | 07-02-2013 | NIFEDIPINE Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386044024 | Labeling: Label Mixup; NIFEDIPINE Capsule, 10 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL W/FLUORIDE, Chew Tablet, 1 mg (F), NDC 64376081501, Pedigree: AD22609_7, EXP: 5/2/2014; NIFEDIPINE, Capsule, 10 mg, NDC 43386044024, Pedigree: AD23082_7, EXP: 9/23/2013. | Aidapak Services, LLC / 202 Capsules | Class II | Terminated |
| D-507-2014 | 07-02-2013 | PARoxetine HCl, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13107015430 | Labeling: Label Mixup; PARoxetine HCl, Tablet, 10 mg may be potentially mislabeled as PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, NDC 62175018046, Pedigree: AD52778_64, EXP: 5/20/2014. | Aidapak Services, LLC / 30 Tablets | Class II | Terminated |
| D-541-2014 | 07-02-2013 | PHYTONADIONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 25010040515 | 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, | Aidapak Services, LLC / 500 Tablets | Class II | Terminated |
| D-733-2014 | 07-02-2013 | MAGNESIUM CHLORIDE, Tablet, 64 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 68585000575 | Labeling:Label Mixup; MAGNESIUM CHLORIDE, Tablet, 64 mg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD52993_31, EXP: 5/17/2014; ASPIRIN EC, Tablet, 325 mg, NDC 00904201360, Pedigree: W003526, EXP: 6/21/2014; NICOTINE POLACRILEX, LOZENGE, 2 mg, NDC 00135051001, Pedigree: W002766, EXP: 6/6/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedig | Aidapak Services, LLC / 720 Tablets | Class II | Terminated |
| D-602-2014 | 07-02-2013 | WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701 | Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014. | Aidapak Services, LLC / 200 Tablets | Class II | Terminated |
| D-625-2014 | 07-02-2013 | CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430 | Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014. | Aidapak Services, LLC / 60 Tablets | Class II | Terminated |
| D-511-2014 | 07-02-2013 | LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668011390 | Labeling: Label Mixup; LOSARTAN POTASSIUM, Tablet, 25 mg may be potentially mislabeled as DISOPYRAMIDE PHOSPHATE, Capsule, 150 mg, NDC 00093312901, Pedigree: AD65323_4, EXP: 5/29/2014. | Aidapak Services, LLC / 180 Tablets | Class II | Terminated |
| D-523-2014 | 07-02-2013 | SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204 | 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, | Aidapak Services, LLC / 500 Tablets | Class II | Terminated |
| D-641-2014 | 07-02-2013 | DARUNAVIR Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59676056630 | Labeling:Label Mixup; DARUNAVIR Tablet, 800 mg may be potentially mislabeled as HYDROcodone BITARTRATE/ ACETAMINOPHEN, Tablet, 7.5 mg/325 mg, NDC 52544016201, Pedigree: W004005, EXP: 7/1/2014. | Aidapak Services, LLC / 90 Tablets | Class II | Terminated |
| D-686-2014 | 07-02-2013 | BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116 | 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. | Aidapak Services, LLC / 32 Lozenges | Class II | Terminated |
| D-540-2014 | 07-02-2013 | CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173 | 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 | Aidapak Services, LLC / 128 Tablets | Class II | Terminated |
| D-639-2014 | 07-02-2013 | ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613 | Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464 | Aidapak Services, LLC / 180 Tablets | Class II | Terminated |
| D-674-2014 | 07-02-2013 | OXcarbazepine Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62756018588 | 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. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-692-2014 | 07-02-2013 | LISINOPRIL Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64679092701 | 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. | Aidapak Services, LLC / 300 Tablets | Class II | Terminated |
| D-528-2014 | 07-02-2013 | metFORMIN HCl Tablet 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155010201 | 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. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-671-2014 | 07-02-2013 | ISOSORBIDE MONONITRATE ER Tablet, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175012837 | 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 | Aidapak Services, LLC / 700 Tablets | Class II | Terminated |
| D-508-2014 | 07-02-2013 | lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 13668004701 | Labeling: Label Mixup; lamotrigine, Tablet, 50 mg (1/2 of 100 mg) may be potentially mislabeled as OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 00603497521, Pedigree: AD73525_64, EXP: 5/30/2014; FEXOFENADINE HCL, Tablet, 60 mg, NDC 45802042578, Pedigree: AD46257_50, EXP: 5/15/2014. | Aidapak Services, LLC / 600 Tablets | Class II | Terminated |
| D-542-2014 | 07-02-2013 | BISOPROLOL FUMARATE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 29300012601 | 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. | Aidapak Services, LLC / 299 Tablets | Class II | Terminated |
| D-550-2014 | 07-02-2013 | NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769 | Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: AD52433_1, EXP: 5/17/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70700_1, EXP: 5/29/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD73623_1, EXP: 5/30/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, | Aidapak Services, LLC / 1,582 Lozenges | Class II | Terminated |
| D-623-2014 | 07-02-2013 | MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130 | Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013. | Aidapak Services, LLC / 60 Tablets | Class II | Terminated |
| D-648-2014 | 07-02-2013 | sulfaSALAzine, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762500001 | Labeling:Label Mixup; sulfaSALAzine Tablet, 500 mg may be potentially mislabeled as HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: AD46265_7, EXP: 5/15/2014. | Aidapak Services, LLC / 100 Tablets | Class II | Terminated |
| D-510-2014 | 07-02-2013 | PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668009690 | Labeling: Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabel as NORTRIPTYLINE HCL, Capsule, 75 mg, NDC 00093081301, Pedigree: W003694, EXP: 6/26/2014. | Aidapak Services, LLC / 90 Tablets | Class II | Terminated |
| D-685-2013 | 07-01-2013 | Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02 Package NDCs: 63323-970-02; 14789-300-02 | Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials | Fresenius Kabi USA, LLC / 65110 vials | Class II | Terminated |
| D-897-2013 | 06-28-2013 | NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 1) 4546 bottles and 2) 1349 bottles | Class III | Terminated |
| D-894-2013 | 06-28-2013 | Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs, Wilmington, DE | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 1) 12,278 and 28476; 2) 23740 | Class III | Terminated |
| D-900-2013 | 06-28-2013 | Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 ) | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 1974 and 3967 physician samples | Class III | Terminated |
| D-896-2013 | 06-28-2013 | Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30) | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / NDC 44118-809-30; 747 and NDC 76331-807-30; 1493 | Class III | Terminated |
| D-899-2013 | 06-28-2013 | Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30) | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 1492 | Class III | Terminated |
| D-898-2013 | 06-28-2013 | Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30 | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 2985 | Class III | Terminated |
| D-895-2013 | 06-28-2013 | Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-807-30) | Subpotent; Beta carotene (Vitamin A) | Stayma Consulting Service, LLC. / 1,460 and 2,990 | Class III | Terminated |
| D-815-2013 | 06-27-2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled | Max Huber Research Labs, Inc. / 49,845 tubes (total for all products) | Class III | Terminated |
| D-814-2013 | 06-27-2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM | Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled | Max Huber Research Labs, Inc. / 49,845 tubes (total for all products) | Class III | Terminated |
| D-816-2013 | 06-27-2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM | Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled | Max Huber Research Labs, Inc. / 49,845 tubes (total for all products) | Class III | Terminated |
| D-1170-2014 | 06-27-2013 | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc / | Class I | Terminated |
| D-1169-2014 | 06-27-2013 | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc / | Class I | Terminated |
| D-813-2013 | 06-27-2013 | Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20. Package NDCs: 0409-4888-02; 0409-4888-10; 0409-4888-03; 0409-4888-20; 0409-4888-06; 0409-4888-50; 0409-4888-01; 0409-4888-12; 0409-4888-90; 0409-1918-42; 0409-1918-32; 0409-1918-43; 0409-1918-33; 0409-1918-45; 0409-1918-35 | Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial. | Hospira Inc. / 268,700 vials | Class II | Terminated |
| D-852-2013 | 06-25-2013 | Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4. | Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date. | Apotex Inc / 50,982 bottles | Class II | Terminated |
| D-804-2013 | 06-24-2013 | Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. | Subpotent Drug; 15-month stability test station | Fresenius Kabi USA, LLC / 221,600 vials | Class II | Terminated |
| D-361-2014 | 06-21-2013 | I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 20,167 bottles | Class III | Terminated |
| D-350-2014 | 06-21-2013 | Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 25,078 bottles | Class III | Terminated |
| D-349-2014 | 06-21-2013 | Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 48,647 bottles | Class III | Terminated |
| D-358-2014 | 06-21-2013 | Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 27,590 bottles | Class III | Terminated |
| D-352-2014 | 06-21-2013 | FOLLOW YOUR DREAMS! Justice, Chocolate anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 65,332 bottles | Class III | Terminated |
| D-360-2014 | 06-21-2013 | GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 9,558 bottles | Class III | Terminated |
| D-365-2014 | 06-21-2013 | BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 4,692 bottles | Class III | Terminated |
| D-364-2014 | 06-21-2013 | yum yum bubble gum Justice, BUBBLEGUM SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 12,326 bottles | Class III | Terminated |
| D-805-2013 | 06-21-2013 | Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 | Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets. | Sandoz Incorporated / 10,848 cartons | Class II | Terminated |
| D-354-2014 | 06-21-2013 | LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 58,054 bottles | Class III | Terminated |
| D-885-2013 | 06-21-2013 | Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40 Package NDCs: 0270-0445-35; 0270-0445-40 | Presence of foreign substance: One lot of the product may contain black foreign particles | Bracco Diagnostics Inc / 29,436 bottles | Class II | Terminated |
| D-363-2014 | 06-21-2013 | YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 15,931 bottles | Class III | Terminated |
| D-359-2014 | 06-21-2013 | Grapefruit anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Tocopheryl Acetate,*** Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 18,492 bottles | Class III | Terminated |
| D-357-2014 | 06-21-2013 | I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 23,231 bottles | Class III | Terminated |
| D-353-2014 | 06-21-2013 | TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 47,343 bottles | Class III | Terminated |
| D-348-2014 | 06-21-2013 | Believe in Yourself Strawberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz., Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 86,701 bottles | Class III | Terminated |
| D-362-2014 | 06-21-2013 | I LOVE BACON Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 16,471 bottles | Class III | Terminated |
| D-351-2014 | 06-21-2013 | Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 Made in China | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 42,570 units | Class III | Terminated |
| D-355-2014 | 06-21-2013 | I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 47,051 bottles | Class III | Terminated |
| D-356-2014 | 06-21-2013 | I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands New Albany, OH 43054 Toronto, ON L6T 3R5 | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl alcohol, but the ethyl alcohol content is 20%. | Tween Brands Inc / 21,201 bottles | Class III | Terminated |
| D-840-2013 | 06-21-2013 | MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30 | Presence of Precipitate; potential for incomplete constitution upon addition of diluent. | AstraZeneca Pharmaceuticals LP / 81,900 total vials | Class II | Terminated |
| D-821-2013 | 06-20-2013 | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30. | Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination. | Gilead Sciences, Inc. / 478,352 vials | Class II | Terminated |
| D-820-2013 | 06-19-2013 | AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30. | Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills. | Astellas Pharma US Inc / 133,550 Vials | Class II | Terminated |
| D-760-2014 | 06-18-2013 | NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-758-2014 | 06-18-2013 | NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9). | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-757-2014 | 06-18-2013 | NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5). | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-763-2014 | 06-18-2013 | Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product) | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-759-2014 | 06-18-2013 | NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product); | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-750-2014 | 06-18-2013 | Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 917,400 cartons | Class II | Terminated |
| D-751-2014 | 06-18-2013 | Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 1,140,564 cartons | Class II | Terminated |
| D-749-2014 | 06-18-2013 | Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 1,871,122 cartons | Class II | Terminated |
| D-754-2014 | 06-18-2013 | Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 292,320 cartons | Class II | Terminated |
| D-753-2014 | 06-18-2013 | Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 868,104 cartons | Class II | Terminated |
| D-762-2014 | 06-18-2013 | Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / | Class II | Terminated |
| D-755-2014 | 06-18-2013 | Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 398,208 cartons | Class II | Terminated |
| D-756-2014 | 06-18-2013 | Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9. | Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. | Novartis Consumer Health / 3,753,348 cartons | Class II | Terminated |
