Drugs

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

Warning Letter — Glow Medispa, LLC dba Mint Med

Warning Letter — Public Health Solution LLC dba DrMedHealth

Warning Letter — Momentum Health 360 dba Momentum Health

Warning Letter — Medica Weight Loss

GUNA-VIRUS — Guna spa drug label update

Convenience Kit Correction: Medline Issues Correction for Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP

Beekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination

FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

Guardian Drug Co. Inc. — Class II: HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle,

Spectra Medical Devices, Llc — Class II: Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectr

Guardian Drug Co. Inc. — Class II: HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED

Guardian Drug Co. Inc. — Class II: CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Di

Guardian Drug Co. Inc. — Class II: HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED

Eugia US LLC — Class III: Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only

FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury

Warning Letter — Macau-Union Pharmaceutical Limited

Warning Letter — Shantou Qiwei Industry Co., LTD

Warning Letter — PLZ Corp

Warning Letter — Fagron BV

Warning Letter — Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

Warning Letter — Umendra Life Sciences Private Limited

Warning Letter — Gopaldas Visram & Co., Ltd.

Warning Letter — Laboratorios Dr. Collado S.A.

Warning Letter — Asanuma Corporation - Sagamihara Factory

BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination

IMPAVIDO — Profounda, Inc. drug label update

Haleon Issues Voluntary Nationwide Recall of Gas-X Extra Strength Softgels 125mg, 120 ct. and 72 ct.

AVEVA Drug Delivery Systems, Inc. — Class III: Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY

AbbVie Inc. — Class III: PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only

NYSTATIN — Kesin Pharma Corporation drug label update

Warning Letter — Laboratorios Jaloma S.A. de C.V.

Warning Letter — HealthPartners Neuroscience Center Research and Innovation

Warning Letter — Aeroflex Industria de Aerosol Ltda.

Warning Letter — Medline Inc

FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs

Aspercreme with Lidocaine No-Mess Applicator — Chattem, Inc. drug label update

Safecor Health, LLC — Class II: Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in car

IntegraDose Compounding Services LLC — Class II: fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDos

Zydus Pharmaceuticals (USA) Inc — Class II: Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus

Zydus Pharmaceuticals (USA) Inc — Class II: Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus

Amerisource Health Services LLC — Class III: Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only

Lupin Pharmaceuticals Inc. — Class II: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceutic

KUGIG ACNE TREATMENT SPRAYER — Guangdong Jiaoyu Biotechnology Co., Ltd. drug label update

Warning Letter — Sato Pharmaceutical Co., Ltd.

Warning Letter — GC America, Inc.

Warning Letter — Aja Health and Wellness Inc.

Warning Letter — GSC Products, LLC

Warning Letter — Alchymars ICM SM Private Limited

Sodium Thiosulfate — Hope Pharmaceuticals drug label update

FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection

Oasis Medical, Inc. — Class II: Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Ma

ENDO USA, Inc. — Class II: Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx only, Manuf

Ascend Laboratories, LLC — Class II: Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx On

Escitalopram — SOLCO HEALTHCARE US, LLC drug label update

Warning Letter — Sourav K. Mishra, M.D. / All India Institute of Medical Sciences

Warning Letter — Hangzhou Yiqi Biotechnology Co., Ltd

Warning Letter — Harbin Jixianglong Biotech Co., Ltd.

Warning Letter — PolleyMed, LLC

Warning Letter — Naseem A. Jaffrani, M.D.

Varibar Thin Honey — E-Z-EM Canada Inc drug label update

Sun Pharmaceutical Industries, Inc. (Sun Pharma) Initiates Voluntary U.S. Nationwide Recall of DOXOrubicin Hydrochloride Liposome Injection 50mg/25 mL Due To Potential Presence of Glass Particles

Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles — Class II: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only,

CareFusion 213, LLC — Class II: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5%

Ajanta Pharma Ltd. — Class II: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b)

Acella Pharmaceuticals, LLC — Class II: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed

JB Chemicals and Pharmaceuticals Ltd — Class II: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Uniqu

Pharmacal Issues Nationwide Recall of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream Due to Microbial Contamination

Warning Letter — ProRx LLC

Warning Letter — IDO Pharm Co., Ltd.

Warning Letter — Naveh Pharma LTD/Bigdam Inc.

Warning Letter — Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre

ZIANA — Bausch Health US, LLC drug label update

FDA Grants Seventh Approval under the National Priority Voucher Pilot Program

FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

ENTERO Vu 24% — E-Z-EM Canada Inc drug label update