Drugs

Warning Letter — Thomas Brunner Hygiene GmbH

Warning Letter — Dabur India Limited

Warning Letter — Woodbine Products Company Inc.

Warning Letter — Maria E. De La Torre Silva, M.D.

Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II: Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2

Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose bliste

Rohto-Mentholatum (Vietnam) Co., Ltd. — Class II: Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%

Fresenius Kabi USA, LLC — Class II: Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL),

Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blis

Major Pharmaceuticals — Class II: Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blist

Chiesi USA, Inc. — Class II: CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials,

Bell Pharmaceuticals, Inc — Class II: QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (

Bell Pharmaceuticals, Inc — Class II: Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%

Bell Pharmaceuticals, Inc — Class II: LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL

Bell Pharmaceuticals, Inc — Class II: FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (

Warning Letter — Almon Healthcare Private Limited

Warning Letter — Shimoga Chemicals

Warning Letter — Island Kinetics, Inc. d.b.a. CoValence Laboratories

Warning Letter — BioMylz Pvt. Ltd.

Warning Letter — Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.

ONESOURCE SPECIALTY PHARMA LIMITED — Class II: Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by

Gasco Industrial Corp. — Class II: Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco In

Gasco Industrial Corp. — Class II: Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR

Reliance Life Sciences Private Limited — Class II: Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous

Gasco Industrial Corp. — Class II: Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drog

Shimoga Chemicals — Class II: Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG

Warning Letter — Spa De Soleil, Inc.

Warning Letter — International Medication Systems Limited

CareFusion 213, LLC — Class II: BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl

CareFusion 213, LLC — Class II: ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcoh

Cipla USA, Inc. — Class II: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla

Asclemed USA Inc. — Class II: Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampu

Warning Letter — LyfeUnit / www.lyfeunit.com

Warning Letter — Keta Med Lab / www.ketamedlab.com

Warning Letter — Ket Plug / ketaminelab.org and buyketaminepowderonline.com

Warning Letter — Ketacyn Pharmaceuticals / www.ketacynpharma.com

Warning Letter — Extra Medication / www.extramedication.com

Warning Letter — All Ketamine HCL / www.allketaminehcl.com

Warning Letter — Ketamine Troche Store / www.ketaminetrochestore.com

Warning Letter — Buy Keta Online / www.buyketaonline.com

Warning Letter — ketaminetroches.com

Warning Letter — Med Shop Inc / www.medshopinc.com

Warning Letter — Ketamine Store / www.ketaminestore.org

Annora Pharma Private Limited — Class II: Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd

Amgen, Inc. — Class II: Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks

Amgen, Inc. — Class II: Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99),

Amgen, Inc. — Class II: Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One

CareFusion 213, LLC — Class II: BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (

Ajanta Pharma USA Inc — Class II: Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Li

Warning Letter — Yangzhou Hongshengding Chemical Co., Ltd.

Warning Letter — Wizcure Pharmaa Private Limited

Warning Letter — Excelvision - Fareva

Fungicure Anti-Fungal Wash — Kobayashi Healthcare International, Inc. drug label update

Prosacea — Kobayashi Healthcare International, Inc. drug label update

Keystone Industries — Class II: DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured

Dabur India Limited — Class II: Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield L

Keystone Industries — Class II: PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufac

Dabur India Limited — Class II: Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin

Dabur India Limited — Class II: Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomyci

Dabur India Limited — Class II: Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate

Warning Letter — MantroForce

Warning Letter — Great India Overseas Pvt. Ltd. dba Silkrute

Warning Letter — Leading Edge Health Inc.

Warning Letter — Indiangoods.shop

Warning Letter — Texinkart Inc.

Warning Letter — Hadassah Healing Oils Ltd

Warning Letter — Wholesale Peptide

Warning Letter — Huons Co., Ltd.

Warning Letter — Jubilant HollisterStier General Partnership

Ascend Laboratories, LLC — Class II: Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only,

Haleon US Holdings LLC — Class I: Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674

SUN PHARMACEUTICAL INDUSTRIES INC — Class II: Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single

Zep Inc — Class II: Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA

Breckenridge Pharmaceutical, Inc. — Class II: Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-

Fresenius Kabi USA, LLC — Class III: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Z

Dehydrated Alcohol — Avenacy, LLC drug label update

Warning Letter — Sante Manufacturing Inc.

Warning Letter — Ready Med

Warning Letter — Maximus Health, Inc. dba Maximus

Warning Letter — Trinity HealthCare Supply, LLC dba altRx