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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 10541–10560 of 17,793 recalls

Class IITerminated

SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy

Key Pharmacy and Compounding Center

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

April 18, 2017 · DrugView details →

Class ITerminated

BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086

Organic Herbal Supply

Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin

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 IITerminated

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC, 6650 Highland Road, Waterford, MI 48327

American Pharmaceutical Ingredients LLC

cGMP Deviations; lack of quality assurance.

April 17, 2017 · DrugView details →

Class IITerminated

EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-020-01

Syntho Pharmaceuticals, Inc.

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

April 17, 2017 · DrugView details →

Class IITerminated

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc., Birmingham, AL 35242, NDC 15310-010-01

Syntho Pharmaceuticals, Inc.

CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.

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 ITerminated

Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged in a) 40-count bottles (NDC 54973-3127-3) (UPC 3 54973 31273 9); b) 135-count bottles (NDC 54973-3127-1) (UPCs 3 54973 31271 5, 3 54973 31371 2, 3 54973 31481 8); and 250-count bottles (NDC 54973-3127-2) (UPCs 3 54973 31272 2, 3 54973 31521 1), Manufactured for: Hyland's, Inc., Los Angeles, CA 90061.

Standard Homeopathic Company

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

April 13, 2017 · DrugView details →

Class IITerminated

Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.

Spectrum Laboratory Products, Inc.

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

April 13, 2017 · DrugView details →

Class IITerminated

Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.

Spectrum Laboratory Products, Inc.

CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.

April 13, 2017 · DrugView details →

Class ITerminated

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA 90061, NDC 54973-3197-1, UPC 3 54973 31971 4.

Standard Homeopathic Company

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

April 13, 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 IITerminated

Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX only, Distributed by Fagron, Inc. 2400 Pilot Knob Rd, St. Paul, MN 55120 Tel. 1-(800) 423-6967 Also packaged as: Estrone USP, For Prescription Compounding, packaged in a) 1 G bottle (NDC 52372-9494-01), b) 5 G bottle (NDC 52372-9494-05), c) 25 G bottle (NDC 52372-9494-03), d) 100 G bottle ( NDC 52372-9494-02), Rx only, Distributed by FREEDOM 801 W. New Orleans St. Broken Arrow, OK 74011 Tel. (877) 839-8547

Fagron, Inc

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

April 6, 2017 · DrugView details →

Class IITerminated

Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →

Class IITerminated

Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →

Class IITerminated

Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →

Class IITerminated

Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →

Class IITerminated

Fentanyl Citrate (Preservative Free) 10 mcg per mL (1,000 mcg per 100 mL) 100 mL total volume in a 100 mL LifeCare Bag in Sodium Chloride 0.9% Rx Only, Compounded by PharMEDium Services, LLC, Cleveland, MS 38732, NDC 61553-112-52.

PharMedium Services, Llc

Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.

April 6, 2017 · DrugView details →

Class IITerminated

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), 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 Also packaged as: Estriol USP Micronized, For prescription compounding, packaged in a 100 G bottle (NDC 52372-9292-01), Rx only, Distributed by FREEDOM, 801 W. New Orleans St. Broken Arrow, OK 74011

Fagron, Inc

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

April 6, 2017 · DrugView details →

Class IITerminated

Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.

Isomeric Pharmacy Solution, LLC

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

April 6, 2017 · DrugView details →

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