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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 10161–10180 of 17,793 recalls

Class IITerminated

Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains 1 Suction toothbrush with sodium bicarbonate, 0.25 fl oz /7ml Perox-A-Mint solution. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6571

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

August 22, 2017 · DrugView details →

Class IITerminated

Q CARE q2 Oral Cleansing & Suctioning System, Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse, 6 Suction Oral Swab packages with Alcohol-Free mouthwash, 4 Oropharyngeal Suction Catheter packages, Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6412 UPC 6 18029 84137 7

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

August 22, 2017 · DrugView details →

Class IITerminated

Q CARE q4 Oral Cleaning & Suctioning System Contains 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages with Antiplaque solution, 4 Suction Oral Swab packages with Antiseptic Oral Rinse. Sage Products, Inc., 3909 Three Oaks Road, Cary, IL 60013. Product Code 6404 UPC 6 18029 84133 9

Sage Products Inc

Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products

August 22, 2017 · DrugView details →

Class IITerminated

Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8

Zydus Pharmaceuticals USA Inc

Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets

August 18, 2017 · DrugView details →

Class IIITerminated

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

VistaPharm, Inc.

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

August 17, 2017 · DrugView details →

Class IITerminated

All Sterile Products within expiry

Vital Rx, Inc. dba Atlantic Pharmacy and Compounding

Lack of Assurance of Sterility .

August 17, 2017 · DrugView details →

Class IITerminated

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

August 16, 2017 · DrugView details →

Class IITerminated

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

August 16, 2017 · DrugView details →

Class IITerminated

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

August 16, 2017 · DrugView details →

Class IITerminated

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL

Pharmatech LLC

Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination

August 16, 2017 · DrugView details →

Class IITerminated

L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.

Bella Pharmaceuticals, Inc.

Lack of Assurance of Sterility.

August 15, 2017 · DrugView details →

Class IITerminated

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

Amphastar Pharmaceuticals, Inc.

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

August 15, 2017 · DrugView details →

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