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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 12901–12920 of 17,816 recalls

Class IIITerminated

Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

Class IIITerminated

Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01

Mutual Pharmaceutical Company, Inc.

Chemical Contamination; benzophenone leached from the product label varnish

July 16, 2015 · DrugView details →

Class IITerminated

SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), biotene¿ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (19.8 g) tubes., (NDC 0135-0557-02) , b) 0.75 oz. (21.3 g) tubes, (NDC 0135-0487-02), c) 4.3 oz. (121.9 g) tubes, (NDC 0135-0557-01), d) 4.5 oz. (127.6 g) tubes, (NDC 0135-0487-01), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IITerminated

SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0548-01); b) 3.4 oz. (96.4 g) tubes, (NDC 0135-0548-02) Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108

GlaxoSmithkline Consmer Healthcare

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

July 15, 2015 · DrugView details →

Class IIITerminated

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA

KVK-Tech, Inc.

Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station

July 14, 2015 · DrugView details →

Class IIITerminated

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

Perrigo Israel Pharmaceuticals

Subpotent drug

July 13, 2015 · DrugView details →

Akttive High Performance Fat Burner Gold dietary supplement capsules, 30-count bottle, Distributed by Life and More, L.L.C., Doral, Florida

Life and More LLC

Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

July 13, 2015 · DrugView details →

Class IIITerminated

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

Purdue Pharma L.P.

Failed dissolution specifications

July 13, 2015 · DrugView details →

Class IITerminated

Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01

PD-Rx Pharmaceuticals, Inc.

cGMP Deviations

July 10, 2015 · DrugView details →

Class IITerminated

Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA, NDC 53489-217-01

Mutual Pharmaceutical Company, Inc.

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

July 9, 2015 · DrugView details →

Class IITerminated

Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA

Mutual Pharmaceutical Company, Inc.

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

July 9, 2015 · DrugView details →

Class IITerminated

Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 53489-216-01) and b) 1000 count (NDC 53489-216-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA.

Mutual Pharmaceutical Company, Inc.

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

July 9, 2015 · DrugView details →

Class IITerminated

Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01

Kremers Urban Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.

July 7, 2015 · DrugView details →

Class IITerminated

Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01

Kremers Urban Pharmaceuticals, Inc.

Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.

July 7, 2015 · DrugView details →

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