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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0.

EAI-JR286

Class I - Dangerous

CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.

Nov 28, 2017 Other Drugs Nationwide View Details →

Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per shelf pack (NDC 0641-6145-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

West-Ward Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Nov 6, 2017 Prescription Drugs Nationwide View Details →

Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties

Class I - Dangerous

GMP Deviations: inadequate manufacturing control processes

Nov 3, 2017 Over-the-Counter View Details →

No. 1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by Shata Traders Inc., 4, 19th Street, Brooklyn, NY 11232. UPC 5842109854239

Shata Trading

Class I - Dangerous

Marketed Without an Approved NDA/ANDA

Aug 22, 2017 Other Drugs View Details →

Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties

Class I - Dangerous

GMP Deviations: inadequate manufacturing control processes

Nov 3, 2017 Over-the-Counter View Details →

Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties

Class I - Dangerous

GMP Deviations: inadequate manufacturing control processes

Nov 3, 2017 Over-the-Counter View Details →

Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01

Amerisource Health Services

Class I - Dangerous

Presence of Foreign Tablets/Capsules.

Oct 24, 2017 Prescription Drugs Nationwide View Details →

Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties

Class I - Dangerous

GMP Deviations: inadequate manufacturing control processes

Nov 3, 2017 Over-the-Counter View Details →

Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05

Leading Pharma

Class I - Dangerous

Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam

Sep 28, 2017 Prescription Drugs Nationwide View Details →

TYVASO (treprostinil) Inhalation Solution Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) Tyvaso Inhalation System Starter Kit Model# TD-100/A, Rx Only, Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709, NDC# 6630220601

United Therapeutics

Class I - Dangerous

CGMP Deviations

Sep 11, 2017 Prescription Drugs View Details →

Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-487-09

Lupin Limited

Class I - Dangerous

Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.

Nov 17, 2017 Prescription Drugs View Details →

Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.

West-Ward Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).

Nov 6, 2017 Prescription Drugs Nationwide View Details →

Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Ridge Properties

Class I - Dangerous

GMP Deviations: inadequate manufacturing control processes

Nov 3, 2017 Over-the-Counter View Details →

Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

Amneal Pharmaceuticals

Class I - Dangerous

Presence of Particulate Matter

Aug 31, 2017 Prescription Drugs View Details →

Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3) and d) 100 G bottle (NDC 51552-1392-5), Rx only, Distributed by Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967

Fagron

Class I - Dangerous

cGMP Deviations: lack of quality assurance at the API manufacturer.

Oct 25, 2017 Prescription Drugs Nationwide View Details →

Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, Rx only, packaged in a) 2.5 mL NDC# 0023-9211-03; b) 5 mL (NDC# 0023-9211-05); c) 10 mL (NDC# 0023-9211-10); d) 15 mL (NDC# 0023-9211-15) bottles, Manufactured By: Allergan, Irvine, CA 92612..

Allergan Sales

Class I - Dangerous

Failed Impurities/Degradation Specifications.

Oct 19, 2017 Prescription Drugs Nationwide View Details →

Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

Genzyme

Class I - Dangerous

Labeling: Incorrect or Missing Package Insert.

Oct 12, 2017 Prescription Drugs Nationwide View Details →

Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottle, Rx only, Allergan, Irvine, CA 92612. NDC# 0023-3205-03

Allergan Sales

Class I - Dangerous

Failed Impurities/Degradation Specifications.

Oct 19, 2017 Prescription Drugs Nationwide View Details →

Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-390-01

Amerisource Health Services

Class I - Dangerous

Failed Stability Specifications

Aug 29, 2017 Prescription Drugs Nationwide View Details →

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

Jubilant Cadista Pharmaceuticals

Class I - Dangerous

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Oct 30, 2017 Prescription Drugs Nationwide View Details →