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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 15101–15120 of 17,832 recalls

Class IIITerminated

Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use only. Physician sample in clamshell container with seven heat-sealed sachets. Rx Only. Watson Pharmaceuticals Inc, Corona, CA, 92890. NDC: 52544-084-77.

Actavis

Subpotent Drug: Drug potency was compromised during shipment.

February 7, 2014 · DrugView details →

Class IITerminated

Alprazolam Extended-Release Tablets, USP, 3 mg, 60-count tablets per bottle, Rx only, Manufactured by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207, NDC 0228-3086-06, UPC 3 0228-3086-06 2.

Actavis Elizabeth LLC

Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.

February 4, 2014 · DrugView details →

Class IIITerminated

Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCl 5 mg) per 5 mL, 8 FL OZ (237 mL) bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-229-08, UPC 6 81131 03884 3.

Aaron Industries Inc

Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.

February 4, 2014 · DrugView details →

Class IIITerminated

SETON PHARMACEUTICALS Fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-507-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-150-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Oil EAR DROPS, 20 ml, Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-508-20

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IITerminated

HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-254-01

American Health Packaging

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

January 31, 2014 · DrugView details →

Class IIITerminated

ROYAL PHARMACEUTICALS DermOtic Oil fluocinolone acetonide 0.01% (Ear Drops), 20 ml, Rx only Manufactured by: Hill Dermaceuticalsfor: Royal Pharmaceuticals NDC 68791-103-20

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IITerminated

HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-TECH, INC. Newtown, PA 18940, NDC 68084-255-01

American Health Packaging

Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.

January 31, 2014 · DrugView details →

Class IIITerminated

Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Scalp Oil), 4 fl. oz., Rx only. Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-149-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

DermOtic Oil (fluocinolone acetonide) 0.01% Ear Drops, 20 mL bottle, Rx only Manufactured and Distributed by: Hill Dermaceuticals, Inc. Sanford, Florida 32773 NDC 28105-160-20

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% Topical Oil (Body Oil) 4 fl. oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. for: Royal Pharmaceuticals NDC 68791-101-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

SETON PHARMACEUTICALS Fluocinolone Acetonide 0.01% Topical Oil (Body Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals, Inc. For: Seton Pharmaceuticals NDC 13925-506-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IIITerminated

ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04

Hill Dermaceuticals, Inc.

Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

January 31, 2014 · DrugView details →

Class IITerminated

Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....

Caraco Pharmaceutical Laboratories Ltd.

Failed Tablet Specifications: Broken Tablets Present.

January 29, 2014 · DrugView details →

Class IIITerminated

Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.

Fougera Pharmaceuticals Inc.

Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.

January 29, 2014 · DrugView details →

Class IITerminated

GREENSTONE BRAND fluconazole for Oral Suspension, ORANGE FLAVORED, 40 mg/mL, when reconstituted, Rx only, Distributed by Greenstone LLC Peapack, NJ 07977. MADE IN INDIA. NDC 59762-5030-1

Pfizer Inc.

Defective Container: Tamper evident ring failures discovered on some bottles.

January 29, 2014 · DrugView details →

Class IIITerminated

Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20

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

Failed Impurity/degradation Specification

January 28, 2014 · DrugView details →

Class IITerminated

Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part FOR INJECTION USE ONLYRX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***

RX South LLC DBA RX3 Pharmacy

Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping

January 28, 2014 · DrugView details →

Class IITerminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI --- NDC 62756-142-02

Caraco Pharmaceutical Laboratories, Ltd.

Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of Metformin HCl ER

January 28, 2014 · DrugView details →

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