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FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Jul 16, 2015

Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 53489-369-01 D-1421-2015

Class III · Low risk Terminated Jul 16, 2015

Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC…

Reason Chemical Contamination; benzophenone leached from the product label varnish

Mutual Pharmaceutical Company, Inc. NDC 53489-368-01 D-1420-2015

Class III · Low risk Terminated Jul 14, 2015

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b)…

Reason Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room…

KVK-Tech, Inc. NDC 10702-0026-01 D-1371-2015

Class III · Low risk Terminated Jul 13, 2015

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by…

Reason Subpotent drug

Perrigo Israel Pharmaceuticals NDC 45802-0119-37 D-1286-2015

Class III · Low risk Terminated Jul 13, 2015

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by…

Reason Failed dissolution specifications

Purdue Pharma L.P. NDC 59011-265-30 D-1278-2015

Class III · Low risk Terminated Jul 6, 2015

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz…

Reason Subpotent Drug: menthol and methyl salicylate below specification

BioComp Pharma, Inc. NDC 0178-0320-12 D-1233-2015

Class III · Low risk Terminated Jul 2, 2015

CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36…

Reason Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.

Bestco, Inc. D-1419-2015

Class III · Low risk Terminated Jun 30, 2015

Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-91070-8, NDC 0135-0135-02), b) 60 count (UPC…

Reason Failed Dissolution Specifications

GlaxoSmithkline Consmer Healthcare NDC 0135-0135-02 D-1287-2015

Class III · Low risk Terminated Jun 29, 2015

HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count…

Reason Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable

Qualitest Pharmaceuticals NDC 0603-3968-21 D-1239-2015

Class III · Low risk Terminated Jun 26, 2015

METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactured by VistaPharm, Inc, Largo, FL. NDC: 66689-031-01.

Reason Defective Container: Lids on unit dose cups are not fully qualified.

VistaPharm, Inc. D-1831-2015

Class III · Low risk Terminated Jun 26, 2015

Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by…

Reason Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

American Health Packaging D-1235-2015

Class III · Low risk Terminated Jun 23, 2015

Desmopressin Acetate Tablets, 0.1mg, 100 Count Bottles, Rx Only. Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale…

Reason Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.

Actavis Laboratories, FL, Inc. D-1285-2015

Class III · Low risk Terminated Jun 23, 2015

CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177…

Reason Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.

Abrams Royal Pharmacy II, LLC NDC 88888-0043-31 D-1231-2015

Class III · Low risk Terminated Jun 18, 2015

Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive…

Reason Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of…

Qualitest Pharmaceuticals NDC 0603-3432-21 D1151-2015

Class III · Low risk Terminated Jun 5, 2015

Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex…

Reason CGMP Deviation: Poor container closure of the bulk storage container

Geritrex Corp NDC 54162-640-03 D-1238-2015

Class III · Low risk Terminated Jun 4, 2015

Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube…

Reason Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

Indiana Botanic Gardens, Inc NDC 10578-035-05 D-1149-2015

Class III · Low risk Terminated Jun 4, 2015

Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets…

Reason Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package…

Actavis Inc NDC 52544-0949-28 D-1148-2015

Class III · Low risk Terminated May 27, 2015

E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a…

Reason Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

Bracco Diagnostic Inc NDC 32909-727-01 D-1147-2015

Class III · Low risk Terminated May 22, 2015

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For…

Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

Novartis Pharmaceuticals Corp. D-1138-2015

Class III · Low risk Terminated May 22, 2015

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For…

Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

Novartis Pharmaceuticals Corp. D-1137-2015

Class III · Low risk Terminated May 19, 2015

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc…

Reason Failed pH Specifications: 12 month stability testing

Hospira Inc. NDC 0409-2168-02 D-1232-2015

Class III · Low risk Terminated May 13, 2015

Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL…

Reason Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

West-Ward Pharmaceutical Corp. NDC 0641-6028-25 D-1139-2015

Class III · Low risk Terminated May 7, 2015

QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120…

Reason Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

Teva Pharmaceuticals USA NDC 59310-0202-12 D-1087-2015

Class III · Low risk Terminated May 6, 2015

Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count…

Reason Subpotent drug

Dr. Reddy's Laboratories, Inc. NDC 43598-316-30 D-1146-2015

Class III · Low risk Terminated May 6, 2015

Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's…

Reason Subpotent drug

Dr. Reddy's Laboratories, Inc. NDC 43598-315-90 D-1145-2015