Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Every FDA drug enforcement recall Public Health Trace has on record, republished from
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Reports. Newly announced recalls may appear on FDA.gov before they become available in
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Showing 15,521–15,540 of 17,987 drug recalls
Drug RecallTerminatedHistorical recordClass II
ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
by The Mentholatum Co.
Reason
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 assurance of sterility controls.
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
by Hospira Inc.
Reason
Lack of Assurance of Sterility; potential leakage from administrative port.
Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
by Hospira Inc.
Reason
Lack of Assurance of Sterility; potential leakage from administrative port.
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: AD52778_88, EXP: 5/21/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00603023516.
by Aidapak Services, LLC
Reason
Labeling: Label Mixup: BISMUTH SUBSALICYLATE, CHEW Tablet, 262 mg may have potentially been mislabeled as the following drug: IRBESARTAN, Tablet, 150 mg, NDC 00093746556, Pedigree: AD42592_7, EXP: 5/14/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup: MINOCYCLINE HCL, Capsule, 50 mg may have potentially been mislabeled as the following drug: MINOXIDIL, Tablet, 2.5 mg, NDC 00591564201, Pedigree: AD52778_49, EXP: 5/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup:predniSONE, Tablet, 20 mg may have potentially been mislabeled as the following drug: methylPREDNISolone, Tablet, 4 mg, NDC 00781502201, Pedigree: AD54587_7, EXP: 5/21/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup: CLINDAMYCIN HCL, Capsule, 300 mg may have potentially been mislabeled as the following drug: MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD68019_7, EXP: 5/28/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: SEVELAMER HCL, Tablet 800 mg, NDC 58468002101, Pedigree: W002858, EXP: 6/7/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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, Pedigree: AD60272_92, EXP: 5/22/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Labeling: Label Mixup: LIOTHYRONINE SODIUM, Tablet, 25 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 175 mcg, NDC 00378181701, Pedigree: W003151, EXP: 6/13/2014; HYOSCYAMINE SULFATE SL, Tablet, 0.125 mg, NDC 00574025001, Pedigree: W003000, EXP: 6/11/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536781601.
by Aidapak Services, LLC
Reason
Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003017, EXP: 6/12/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
VITAMIN B COMPLEX W/C, Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536730001.
by Aidapak Services, LLC
Reason
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, EXP: 5/20/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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: 5/16/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
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: 5/16/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
VITAMIN B COMPLEX, Capsule, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536478701.
by Aidapak Services, LLC
Reason
Labeling: Label Mixup: VITAMIN B COMPLEX, Capsule, 0 mg may have potentially been mislabeled as the following drug: ACARBOSE, Tablet, 25 mg, NDC 23155014701, Pedigree: AD32757_1, EXP: 5/13/2014.
Recall initiated
July 2, 2013
Reported by FDA
January 29, 2014
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.
