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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 5741–5760 of 17,755 recalls

Class IITerminated

Minoxidil/Biotin/Spironolactone 1.25/5/25mg capsules, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →

Class IITerminated

bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL), Distributed By: Payless Janitorial Corporation 1341 SW 21 Terrance, Fort Lauderdale, Florida Exported By: E. Audicode S.A. de C.V. Manufactured By: AAA Cosmetica S.A. de C.V. UPC 7 502272 12111 5

AAA Cosmetica, SA de CV

CGMP Deviations

July 2, 2020 · DrugView details →

Class IITerminated

Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →

Class IITerminated

Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →

Class IITerminated

Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

MasterPharm LLC

Lack of Processing Controls (lack of assurance of conformity to specifications).

July 2, 2020 · DrugView details →

Class IITerminated

Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions.

Preferred Pharmaceuticals, Inc.

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

July 1, 2020 · DrugView details →

Class ITerminated

Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.

Spartan Chemical Co Inc

Microbial contamination of non-sterile products: positive microbial contamination in product.

July 1, 2020 · DrugView details →

Class ITerminated

Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6

Transliquid Technologies, LLC

Chemical Contamination: Presence of Undeclared Methanol

June 29, 2020 · DrugView details →

Class IITerminated

Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1

EMD Serono, Inc.

Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.

June 29, 2020 · DrugView details →

Class IITerminated

Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.

RemedyRepack Inc.

FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.

June 29, 2020 · DrugView details →

Class IITerminated

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.

POLARIZED LLC

CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.

June 25, 2020 · DrugView details →

Class ITerminated

Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX Only, Medichem, S.A. Poligono Industrial Celra, 17460, Celra, Girona (Spain/Espana); Fructuos Gelabert, 6-8, 08970, Sant Joan Despi, Barcelona (Spain/Espana) NDC 53296-0012-0

Medichem S.A.

Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches

June 24, 2020 · DrugView details →

Class ITerminated

All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0

Itech 361 LLC

Chemical Contamination: Product contains undeclared methanol.

June 23, 2020 · DrugView details →

Class IIITerminated

Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02

Biogen MA Inc.

cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.

June 23, 2020 · DrugView details →

Class ITerminated

ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11

CareFusion 213, LLC

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

June 23, 2020 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →

Class ITerminated

BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32

CareFusion 213, LLC

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

June 23, 2020 · DrugView details →

Class ITerminated

ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01

CareFusion 213, LLC

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

June 23, 2020 · DrugView details →

Class IIITerminated

Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.

VistaPharm, Inc.

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

June 23, 2020 · DrugView details →

Class ITerminated

Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distributed by Polarized, LLC, Produced by Eskbiochem SA de CV, Mexico Japon 50, Celaya, Gto., Mexico, 38010. UPC 8 60003 63391 5.

UVT INC

Chemical Contamination: Product contains undeclared methanol.

June 22, 2020 · DrugView details →

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