Drugs

Warning Letter — Guangdong Bangze Medicine Co., Ltd.

Warning Letter — New Green Nutrition Inc.

Warning Letter — Ong Tien USA LLC

Warning Letter — Bella’s Nutri Shop Inc.

Warning Letter — Jing Cheong Asia Inc. dba New York Tong Ren Tang

Warning Letter — Conroe Welding Supply, Inc.

Warning Letter — Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.

Warning Letter — RonanRx, Inc. dba RonanRx

Warning Letter — Pritam International Private Limited

HERA SILKYSTAY FOUNDATION 37W1 — Amorepacific Corporation drug label update

PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, Mint Chocolate Chip Ice Cream Flavored Toothpaste, Anticavity Fluoride Toot

Par Health USA, LLC — Class I: Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only,

PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: evo, Sensitive, Anticavity Fluoride Toothpaste, (potassium nitrate 5%, sodium fluoride 0.2

PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, Crayola, Silly Scents, Anticavity Fluoride Toothpaste, (sodium fluoride0.24

PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: BB (Brush Buddies) Advanced Whitening, Anti-Cavity Fluoride Toothpaste, (sodium fluoride 0

PRITAM INTERNATIONAL PRIVATE LIMITED — Class II: Brush Buddies, My Little Pony Scents Anticavity Fluoride Toothpaste, (sodium fluoride 0.24

Warning Letter — Northland Nuclear Medicine, LLC

Warning Letter — Sanrace Biotechnology Co., Ltd.

Warning Letter — TSP Solutions Pte. Ltd.

Warning Letter — Amgen Inc.

Houston Rx LLC — Class II: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 154

Teva Pharmaceuticals USA, Inc — Class II: Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured

American Health Packaging — Class II: Metoclopramide Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only, Distributed by: America

Zydus Pharmaceuticals (USA) Inc — Class II: Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactu

Houston Rx LLC — Class II: Tirzepatide/Niacinamide 2mL vial (40 MG per Vial) Inj 20mg/2mg/mL, RX Only, Houston RX LLC

Warning Letter — Baxter International Inc.

Warning Letter — SnugZ USA, Inc.

Warning Letter — Signature Formulations LLC

Warning Letter — Rohto Pharmaceutical Co., Ltd.

K.C. Pharmaceuticals, Inc. — Class II: Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY C

Carolina Infusion, LLC — Class II: QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, to

Carolina Infusion, LLC — Class II: TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes,

Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes

Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes

Carolina Infusion, LLC — Class II: Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes,

Warning Letter — SCA Pharmaceuticals, LLC

Warning Letter — Jiangmen Shuizirun Sanitary Articles Co., Ltd.

Warning Letter — Hanlim Pharm Co., Ltd.

Warning Letter — Eurofins SF Analytical Laboratories, Inc.

SV Labs Toronto Corporation — Class II: Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63),

Amneal Pharmaceuticals, LLC — Class II: Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharm

Aurolab Trust — Class II: FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for:

Apotex Corp. — Class II: Paroxetine Extended-Release Tablets, 37.5mg, 30-count bottle, Rx only, Manufactured by: Ap

TerSera Therapeutics LLC — Class II: Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only,

Warning Letter — Terramed

Warning Letter — DesBio/Deseret Biologicals, Inc.

Warning Letter — Aidance Scientific, Inc.

Warning Letter — The Platinum Healthcare LLC

Warning Letter — Graceful Touch, LLC

Warning Letter — Walmart, Inc.

Sterling Pharmaceutical Services LLC — Class II: TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.

Sterling Pharmaceutical Services LLC — Class II: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Steril

Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company — Class II: Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoli

Sterling Pharmaceutical Services LLC — Class II: Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile,

Sterling Pharmaceutical Services LLC — Class II: Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubri

Warning Letter — Babikian Healthcare Products CJSC

Warning Letter — Fresenius Kabi AG

Warning Letter — Bentley Laboratories LLC

Warning Letter — Curia New York, Inc.

Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1

Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1

Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1

Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14

VITRUVIAS THERAPEUTICS INC — Class I: Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg,

Safecor Health, LLC — Class II: Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1

Warning Letter — kdc/one Chatsworth, Inc.

Warning Letter — Empower Clinic Services, LLC dba Empower Pharmacy

ImprimisRx NJ LLC — Class III: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottl

Baxter Healthcare Corporation — Class I: Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfi

OurPharma LLC — Not Yet Classified: fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag,

Ajanta Pharma USA Inc — Class III: Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Aj

FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use

Baxter Healthcare Corporation — Class II: Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Sing

Baxter Healthcare Corporation — Class II: Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL

Baxter Healthcare Corporation — Class II: Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg to

Baxter Healthcare Corporation — Class II: CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL

Supernus Pharmaceuticals, Inc. — Class III: Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufact

Teva Pharmaceuticals USA, Inc — Class II: traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia

Warning Letter — Happy Farm Botanicals, Inc.

ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC