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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 761–780 of 1,000 recalls

Class IIITerminated

Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01

Hetero USA Inc

Presence of Foreign Substance: human hair melded into tablet.

April 27, 2017 · DrugView details →

Class IIITerminated

Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8

Noven Pharmaceuticals, Inc.

Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

April 27, 2017 · DrugView details →

Class IIITerminated

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20

Sandoz Inc

Subpotent Drug; Clavulanic Acid

April 26, 2017 · DrugView details →

Class IIITerminated

IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

Akorn, Inc.

Product is being recalled due to low pH value.

April 20, 2017 · DrugView details →

Class IIITerminated

Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol - 389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-343-83.

Sun Pharmaceutical Industries, Inc.

Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

April 18, 2017 · DrugView details →

Class IIITerminated

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

Fagron, Inc

Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

April 17, 2017 · DrugView details →

Class IIITerminated

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, NDC 36800-483-24, UPC 0-36800-39134-5; (b) Rexall Since 1903 Allergy Relief, PACKAGED FOR DOLGENCORP, LLC, 100 MISSION RIDGE GOODLETTSVILLE, TN 37072, UPC 3-59726-72025-0; (c) HyVee health Allergy Relief, DISTRIBUTED BY HY-VEE, INC. 5820 WESTOWN PARKWAY, WEST DES MOINES, IA 50266, NDC 42507-483-24, UPC 0-75450-12369-2; (d) up & up allergy relief, Distributed by Target Corporation, Minneapolis, MN 55403, NDC 11673-720-24, UPC 3-59726-72025-0; (e) smart sense allergy softgels, Distributed by Kmart Corporation, Hoffman Estates, IL 60179, NDC 49738-483-24, UPC 8-83967-39839-3.

P & L Development, LLC

Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

April 17, 2017 · DrugView details →

Class IIITerminated

Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, Inc. Buena. New Jersey 08310 NDC 52565-030-15

Teligent, Inc.

Superpotent Drug

April 7, 2017 · DrugView details →

Class IIITerminated

Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19

West-Ward Columbus, Inc.

Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

April 4, 2017 · DrugView details →

Class IIITerminated

PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87

Teva Pharmaceuticals USA

Failed Stability Specifications

March 28, 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 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 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 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 →

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