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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 10581–10600 of 17,793 recalls

Class IITerminated

Estradiol Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →

Class IITerminated

Ethinyl Estradiol Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd, Qinhuangdao 066004, China (NDC 44132-002-05)

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →

Class IITerminated

Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),

Qinhuangdao Zizhu Pharmaceutical, Co.

cGMP Deviations; lack of quality assurance.

March 24, 2017 · DrugView details →

Class IIITerminated

Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

March 22, 2017 · DrugView details →

Class IIITerminated

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15

Novartis Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications.

March 22, 2017 · DrugView details →

Class IIITerminated

Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

March 22, 2017 · DrugView details →

Class IIOngoing

Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.

GlaxoSmithKline, LLC

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

March 22, 2017 · DrugView details →

Class IIITerminated

Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

March 22, 2017 · DrugView details →

Class IIITerminated

Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

Sun Pharmaceutical Industries, Inc.

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

March 22, 2017 · DrugView details →

Class IIITerminated

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

Novartis Pharmaceuticals Corp.

Failed Impurities/Degradation Specifications.

March 22, 2017 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

March 21, 2017 · DrugView details →

Class IIITerminated

CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 mL), Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA. Product SKU 301876102042, NDC 0187-6102-04

Valeant Pharmaceuticals North America LLC

Discoloration.

March 20, 2017 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 0378-3950-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Mylan Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

March 20, 2017 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Mylan Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

March 20, 2017 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 20 mg*, packaged in a) 90-count bottles (NDC 0378-3951-09) and b) 500-count bottles (NDC 0378-3951-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Mylan Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

March 20, 2017 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 80 mg*, packaged in a) 90-count bottles (NDC 0378-3953-09) and b) 500-count bottles (NDC 0378-3953-07), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Mylan Pharmaceuticals Inc.

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.

March 20, 2017 · DrugView details →

Class IIITerminated

CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotion (benzoyl peroxide 5% Acne Treatment) 47mL bottle, b) Daily Care Foaming Cleanser (Salicylic Acid 2% Acne Treatment) 118 mL bottle, c) Salicylic Acid 2% Acne Treatment 148mL, Valeant Pharmaceuticals North America LLC Distributed by OMP, Inc Long Beach, CA 90806 Made in USA, Product SKU 301876103018, NDC 0187-6103-01

Valeant Pharmaceuticals North America LLC

Discoloration.

March 20, 2017 · DrugView details →

Class IIITerminated

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15), b) 30 g tubes (NDC 0713-0638-31), and c) 90 g tubes (NDC 0713-0638-18), Rx only, Manufactured by: G&W Laboratories, Inc., South Plainfeld, NJ 07080.

G & W Laboratories, Inc.

Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert.

March 20, 2017 · DrugView details →

Class IIITerminated

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

Taro Pharmaceuticals U.S.A., Inc.

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

March 17, 2017 · DrugView details →

Class IITerminated

Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, MA. NDC47783-101-01

Shire

Presence of Particulate Matter: Glass

March 17, 2017 · DrugView details →

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