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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 16781–16800 of 17,860 recalls

Class IITerminated

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IIITerminated

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

May 15, 2013 · DrugView details →

Class IIITerminated

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24.

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

May 15, 2013 · DrugView details →

Class IITerminated

Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Pentec Health

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

May 15, 2013 · DrugView details →

Class IITerminated

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA

Actavis South Atlantic LLC

Failed Impurity/Degradation Specification; "Related Compound C"

May 15, 2013 · DrugView details →

Class IIITerminated

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2081-24

Novartis Consumer Health

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

May 15, 2013 · DrugView details →

Class ITerminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10

Zydus Pharmaceuticals USA Inc

Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.

May 13, 2013 · DrugView details →

Class ITerminated

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy, Dallas, TX

Abrams Royal Pharmacy

Non-Sterility; contract laboratory identified Staphylococcus warneri in the product

May 13, 2013 · DrugView details →

Class IIITerminated

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10

West-ward Pharmaceutical Corp.

Failed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)

May 13, 2013 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0

Apotex Corp.

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

May 10, 2013 · DrugView details →

Class IITerminated

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Fusion Pharmaceuticals, LLC

Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

May 8, 2013 · DrugView details →

Class IIITerminated

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, 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.

May 7, 2013 · DrugView details →

Class ITerminated

Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).

Chang Kwung Products

Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

May 6, 2013 · DrugView details →

Class ITerminated

Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).

Chang Kwung Products

Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active ingredient in an FDA-approved product indicated for the treatment of male erectile dysfunction (ED), making this product an unapproved new drug.

May 6, 2013 · DrugView details →

Class IITerminated

Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2

Kareway Product Inc

Labeling: Not Elsewhere Classified; foil label on immediate blister pack indicates active ingredient as Chlorpheniramine rather than Diphenhydramine

May 3, 2013 · DrugView details →

Class IITerminated

Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

May 2, 2013 · DrugView details →

Class IITerminated

Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

THE COMPOUNDING SHOP, INC.

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

May 2, 2013 · DrugView details →

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