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FDA Drug Recalls

14,450 recalls · Class II, newest first

Class II · Moderate risk Terminated Jan 8, 2016

Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the…

Reason Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

Perrigo Company PLC NDC 37808-288-26 D-0586-2016

Class II · Moderate risk Terminated Jan 5, 2016

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan…

Reason Lack of Assurance of Sterility: Failed preservative effectiveness test

Mayne Pharma Usa NDC 0378-7110-35 D-0585-2016

Class II · Moderate risk Terminated Dec 29, 2015

Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023

Reason Lack of assurance of sterility

TexasStar Pharmacy D-0733-2016

Class II · Moderate risk Terminated Dec 24, 2015

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ…

Reason Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Macleods Pharma Usa Inc D-0653-2016

Class II · Moderate risk Terminated Dec 24, 2015

IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded…

Reason Lack of Assurance of Sterility

Amerita Specialty Infusion Services D-0570-2016

Class II · Moderate risk Terminated Dec 24, 2015

Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

Reason Lack of Assurance of Sterility

Amerita Specialty Infusion Services D-0569-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0135-1 D-0580-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0134-1 D-0579-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0137-1 D-0578-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0133-1 D-0577-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0132-1 D-0576-2016

Class II · Moderate risk Terminated Dec 22, 2015

Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by…

Reason Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count

Grato Holdings, Inc. NDC 44911-0136-1 D-0575-2016

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5555-3 D-1440-2016

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5554-3 D-1439-2016

Class II · Moderate risk Terminated Dec 21, 2015

Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 mg/hr), packaged in 30-count patches per…

Reason Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients…

Noven Pharmaceuticals, Inc. NDC 68968-5553-3 D-1438-2016

Class II · Moderate risk Terminated Dec 21, 2015

Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech…

Reason Failed Dissolution Specifications: low test results at the 18 month time-point

Teva North America NDC 0093-7474-89 D-0732-2016

Class II · Moderate risk Terminated Dec 3, 2015

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation…

Reason Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of…

GlaxoSmithKline, LLC NDC 0173-0682-20 D-0519-2016

Class II · Moderate risk Terminated Nov 29, 2015

Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01

Reason cGMP Deviations; trailer may not have met GMP requirements prior to filling

AGA Gas Inc NDC 33237-001-01 D-0779-2016

Class II · Moderate risk Terminated Nov 12, 2015

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a…

Reason Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

Teva Pharmaceuticals USA NDC 0555-0972-02 D-0566-2016

Class II · Moderate risk Terminated Nov 12, 2015

tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G, Distributed by: Tubby Todd Bath Co. Vista, CA…

Reason Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of specification for mold.

Mariposa Labs LLC D-0510-2019

Class II · Moderate risk Terminated Nov 11, 2015

SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in…

Reason Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.

Fagron, Inc NDC 51552-1079-9 D-0656-2016

Class II · Moderate risk Terminated Nov 11, 2015

SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated…

Reason Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.

Fagron, Inc NDC 51552-1167-9 D-0655-2016

Class II · Moderate risk Terminated Nov 11, 2015

SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous…

Reason Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.

Fagron, Inc NDC 51552-1079-5 D-0654-2016

Class II · Moderate risk Terminated Nov 11, 2015

Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRepack…

Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

RemedyRepack Inc. NDC 61786-0222-57 D-0517-2016

Class II · Moderate risk Terminated Nov 11, 2015

Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by…

Reason Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.

RemedyRepack Inc. NDC 52125-0414-01 D-0516-2016