DrugFeb 5, 2014
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg recall — FDA D-1043-2014
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class IIIFDA: TerminatedActavis Inc.
Monthly breakdown
2014 recalls by month
Select a month to review the recall records reported during that period.
December 2014206 records · 2 categoriesNovember 2014617 records · 2 categoriesOctober 2014159 records · 2 categoriesSeptember 2014101 records · 2 categoriesAugust 2014118 records · 2 categoriesJuly 2014224 records · 3 categoriesJune 201483 records · 2 categoriesMay 2014120 records · 2 categoriesApril 2014219 records · 2 categoriesMarch 2014137 records · 2 categoriesFebruary 201484 records · 2 categories
2014 recalls — page 87
Records are ordered by the best available source date.
DrugFeb 5, 2014
The Mentholatum Co ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net recall — FDA D-1039-2014
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Class IIFDA: TerminatedThe Mentholatum Co.
DrugFeb 5, 2014
Humco Holding Group Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and recall — FDA D-1048-2014
Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.
Class IIFDA: TerminatedHumco Holding Group, Inc.
DrugFeb 5, 2014
The Mentholatum Co ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief recall — FDA D-1040-2014
Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality…
Class IIFDA: TerminatedThe Mentholatum Co.
DrugJan 29, 2014
Aidapak Services MERCapsuleTOPURINE, Tablet, 50 mg recall — FDA D-799-2014
Labeling: Label Mixup: MERCapsuleTOPURINE, Tablet, 50 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 500 mg, NDC 00904052380, Pedigree: AD54576_4,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services SELENIUM, Tablet, 50 mcg, Over The Counter recall — FDA D-1029-2014
Labeling: Label Mixup :SELENIUM, Tablet, 50 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000815, Pedigree: AD56917_13, EXP:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services VENLAFAXINE HCL, Tablet, 100 mg recall — FDA D-847-2014
Labeling: Label Mixup: VENLAFAXINE HCL, Tablet, 100 mg may have potentially was mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD73525_31, EXP: 5/30/2014; and may…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services ASCORBIC ACID, Tablet, 500 mg, Over The Counter recall — FDA D-1019-2014
Labeling: Label Mixup: ASCORBIC ACID, Tablet, 500 mg may have potentially been mislabeled as the following drug: VENLAFAXINE HCL, Tablet, 100 mg, NDC 00093738301, Pedigree: AD42566_1, EXP:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Novartis Consumer Health Theraflu Flu & Sore Throat recall — FDA D-748-2014
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class IIFDA: TerminatedNovartis Consumer Health
DrugJan 29, 2014
Aidapak Services CALCITRIOL, Capsule, 0.25 mcg recall — FDA D-787-2014
Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014;…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services POTASSIUM ACID PHOSPHATE, Tablet, 500 mg recall — FDA D-916-2014
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,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) recall — FDA D-960-2014
Labeling: Label Mixup: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: traMADol HCl, Tablet, 25 mg (1/2 of 50 mg), NDC 57664037708,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services NIACIN TR, Tablet, 1000 mg recall — FDA D-945-2014
Labeling: Label Mixup: NIACIN TR, Tablet, 1000 mg may have potentially been mislabeled as the following drug: NIACIN TR, Tablet, 750 mg, NDC 00536703301, Pedigree: AD46414_56, EXP:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter recall — FDA D-947-2014
Labeling: Label Mixup: VITAMIN B COMPLEX W/C, Tablet, 0 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD54516_4,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services RILUZOLE, Tablet, 50 mg recall — FDA D-813-2014
Labeling: Label Mixup: RILUZOLE, Tablet, 50 mg may have potentially been mislabeled as the following drug: LACTOBACILLUS, Tablet, 0 mg, NDC 64980012950, Pedigree: AD62986_10, EXP: 5/23/2014.
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services MYCOPHENOLATE MOFETIL, Capsule, 250 mg recall — FDA D-771-2014
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services ASCORBIC ACID, Tablet, 250 mg, Over The Counter recall — FDA D-1018-2014
Labeling: Label Mixup: ASCORBIC ACID, Tablet, 250 mg may have potentially been mislabeled as one of the following drugs: PREGABALIN, Capsule, 200 mg, NDC 00071101768, Pedigree: AD30024_1,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services NIACIN TR, Tablet, 750 mg recall — FDA D-944-2014
Labeling: Label Mixup: NIACIN TR, Tablet, 750 mg may have potentially been mislabeled as the following drug: NORTRIPTYLINE HCL, Capsule, 50 mg, NDC 00093081201, Pedigree: AD46414_47, EXP:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services PIOGLITAZONE, Tablet, 15 mg recall — FDA D-971-2014
Labeling: Label Mixup: PIOGLITAZONE, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: LACTASE ENZYME, Tablet, 3000 units, NDC 24385014976, Pedigree:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles recall — FDA D-1032-2014
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugJan 29, 2014
Aidapak Services TRIFLUOPERAZINE HCL, Tablet, 1 mg recall — FDA D-997-2014
Labeling: Label Mixup: TRIFLUOPERAZINE HCL, Tablet, 1 mg may have potentially been mislabeled as the following drug: TERBUTALINE SULFATE, Tablet, 2.5 mg, NDC 00115261101, Pedigree:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg recall — FDA D-980-2014
Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree:…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services TEMAZEPAM, Capsule, 7.5 mg recall — FDA D-905-2014
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,…
Class IIFDA: TerminatedAidapak Services, LLC
DrugJan 29, 2014
Aidapak Services CapsuleTOPRIL, Tablet, 12.5 mg recall — FDA D-863-2014
Labeling: Label Mixup: CapsuleTOPRIL, Tablet, 12.5 mg may have potentially been mislabeled as the following drug:, CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: AD52778_13, EXP:…
Class IIFDA: TerminatedAidapak Services, LLC
About the 2014 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.