Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIISOSORBIDE DINITRATE, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781163501.
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: CILOSTAZOL, Tablet, 100 mg, NDC 00054004421, Pedigree: W003470, EXP: 6/20/2014; PERPHENAZINE, Tablet, 8 mg, NDC 00630506221, Pedigree: AD54605_1, EXP: 4/30/2014.
- 2014-01-29FDA-DrugAidapak Services, LLCClass IIISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.
Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.
- 2014-01-22FDA-DrugPfizer Inc.Class IIIZithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84
Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIIExcedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIITheraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24). Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIITheraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIIMaximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIIMaximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIIMaximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- 2014-01-22FDA-DrugNovartis Consumer HealthClass IIIMaximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.
- 2014-01-22FDA-DrugGreenstone LlcClass IINifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8
Labeling: Incorrect or Missing Lot and/or Exp Date: Greenstone LLC is recalling Nifedipine Extended Release tablets (90mg). The expiration date on the package is 48 months instead of 36 months.
- 2014-01-22FDA-DrugSigma-Tau Pharmaceuticals, Inc.Class IIPEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01
Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIHYOSCYAMINE SULFATE SL Tablet, 0.125 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 76439030910
Labeling:Label Mixup; HYOSCYAMINE SULFATE SL Tablet, 0.125 mg may be potentially mislabeled as azaTHIOprine, Tablet, 50 mg, NDC 00054408425, Pedigree: AD56832_1, EXP: 5/21/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W003464, EXP: 6/20/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIMELATONIN, Tablet, 1 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 74312002832
Labeling:Label Mixup; MELATONIN, Tablet, 1 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W003711, EXP: 6/26/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIMAGNESIUM 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
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIRASAGILINE MESYLATE, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68546014256
Labeling:Label Mixup; RASAGILINE MESYLATE, Tablet, 0.5 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002690, EXP: 6/5/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIPRAMIPEXOLE DI-HCL, Tablet, 1.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462033490
Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD68010_11, EXP: 5/28/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIVERAPAMIL HCL ER, Tablet, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462026001
Labeling:Label Mixup; VERAPAMIL HCL ER, Tablet, 240 mg may be potentially mislabeled as TRIFLUOPERAZINE HCL, Tablet, 1 mg, NDC 00781103001, Pedigree: AD52778_91, EXP: 5/21/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIFLUCONAZOLE, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010230
Labeling:Label Mixup; FLUCONAZOLE, Tablet, 100 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: W003086, EXP: 6/12/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIFLUCONAZOLE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68462010130
Labeling:Label Mixup; FLUCONAZOLE, Tablet, 50 mg may be potentially mislabeled as FLUCONAZOLE, Tablet, 200 mg, NDC 00172541360, Pedigree: W003065, EXP: 6/12/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIRIBAVIRIN, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382026007
Labeling:Label Mixup; RIBAVIRIN, Capsule, 200 mg may be potentially mislabeled as MODAFINIL, Tablet, 50 mg (1/2 of 100 MG Tablet), NDC 55253080130, Pedigree: AD21787_4, EXP: 5/1/2014; DESIPRAMINE HCL, Tablet, 50 mg, NDC 45963034302, Pedigree: AD30140_7, EXP: 5/7/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIamLODIPine BESYLATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68382012316
Labeling:Label Mixup; amLODIPine BESYLATE, Tablet, 10 mg may be potentially mislabeled as FINASTERIDE, Tablet, 5 mg, NDC 16714052201, Pedigree: AD62846_1, EXP: 2/28/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIRAMIPRIL, Capsule, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180058901
Labeling:Label Mixup; RAMIPRIL, Capsule, 2.5 mg, Rx only may be potentially mislabeled as PROPAFENONE HCL, Tablet, 150 mg, NDC 00591058201, Pedigree: AD54549_13, EXP: 5/20/2014; CALCIUM POLYCARBOPHIL, Tablet, 625 mg, NDC 00536430611, Pedigree: AD73592_11, EXP: 5/31/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIQUINAPRIL HCL, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 68180055809
Labeling:Label Mixup; QUINAPRIL HCL, Tablet, 20 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 65162066850, Pedigree: W003553, EXP: 6/24/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIIBUPROFEN, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67877029401
Labeling:Label Mixup; IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002573, EXP: 6/3/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIbuPROPion HCl ER (XL), Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 67767014130
Labeling:Label Mixup; buPROPion HCl ER (XL), Tablet, 150 mg may be potentially mislabeled as MESALAMINE CR, Capsule, 250 mg, NDC 54092018981, Pedigree: AD52412_1, EXP: 5/17/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIDOCUSATE SODIUM, Capsule, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 67618010060
Labeling:Label Mixup; DOCUSATE SODIUM, Capsule, 50 mg may be potentially mislabeled as LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD60211_1, EXP: 5/21/2014; MEXILETINE HCL, Capsule, 150 mg, NDC 00093873901, Pedigree: AD62865_7, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 5000 units, NDC 00761017840, Pedigree: AD65457_10, EXP: 5/24/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IISELEGILINE 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.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIcarBAMazepine ER, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66993040832
Labeling:Label Mixup; carBAMazepine ER, Capsule, 200 mg may be potentially mislabeled as ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD46333_1, EXP: 5/15/2014.
- 2014-01-22FDA-DrugAidapak Services, LLCClass IIPHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 66213042510
Labeling:Label Mixup; PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg may be potentially mislabeled as VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: W003639, EXP: 6/25/2014.
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