Drugs

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

Hikma Pharmaceuticals USA INC. — Class II: Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Ca

ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufact

ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufac

ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (ND

ACCORD HEALTHCARE, INC. — Class II: Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufa

Warning Letter — Peak Performance Peptides

Warning Letter — Reliance Life Sciences Private Limited

Warning Letter — Jabil Inc.

Warning Letter — Shoolin Pharma Chem LLP

FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels

Warning Letter — Royal Peptides LLC

Warning Letter — NuScience Peptides LLC

Warning Letter — TXP Innovations LLC dba Tex Peptides

Buy-Herbal — Class I: Kian Pee Wan Capsules, 30-count bottles

Shoolin Pharma Chem LLP — Class II: SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding

Apollo Care, LLC — Class II: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx On

Apollo Care, LLC — Class II: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous

Victory Medical Center Pharmacy — Class I: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Ac

Apollo Care, LLC — Class II: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Inj

Warning Letter — Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.

Warning Letter — Safrel Pharmaceuticals LLC

Warning Letter — Suretec Innovations, LLC

Warning Letter — K.C. Pharmaceuticals, Inc.

Warning Letter — Eugia Pharma Specialities Limited

Aurobindo Pharma USA Inc — Class II: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aur

Sunny Pharmtech Inc. — Class I: Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactu

Central Admixture Pharmacy Services Inc — Class III: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Com

Zydus Pharmaceuticals (USA) Inc — Class II: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zyd

Sunny Pharmtech Inc. — Class I: Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactu

Warning Letter — FairyGene, Inc.

Warning Letter — Lico Industries, LLC., d.b.a. American Towelette Company

Glenmark Pharmaceuticals Inc., USA — Class II: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenm

MYLAN PHARMACEUTICALS INC — Class II: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton

MICRO LABS USA INC — Class II: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx o

Ascend Laboratories, LLC — Class III: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a ca

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