January 17, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally,
Hazard: Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
January 10, 2024DrugsFDA
Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Med
Hazard: Lack of Sterility Assurance
January 10, 2024DrugsFDA
Seaway Pharma Inc. recalls Quality Choice No Drip Severe Congestion Nasal Pump Mist, Oxymetazoline hydrochloride 0.05%, Nasal Decongestant, 12 Hour
Hazard: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
January 10, 2024DrugsFDA
Seaway Pharma Inc. recalls Quality Choice No Drip Extra Moisturizing Nasal Pump Mist Oxymetazoline hydrochloride 0.05%, 12 Hour Nasal Decongestant,
Hazard: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
January 10, 2024DrugsFDA
Seaway Pharma Inc. recalls Premier Value Tussin Cough DM, Dextromethorphan HBr...Cough Suppressant, Guaifenesin...Expectorant, Alcohol Free, 8 FL O
Hazard: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
January 10, 2024DrugsFDA
Seaway Pharma Inc. recalls Nasal Spray Original No Drip Oxymetazoline HCl Nasal Solution, 12 Hour Pump Mist, 1 FL oz. (30 mL) bottle, a) Quality Ch
Hazard: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
January 10, 2024DrugsFDA
Azurity Pharmaceuticals, Inc. recalls Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn
Hazard: Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
January 3, 2024DrugsFDA
TCP HRB ACQUISITON LLC recalls Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Distr
Hazard: Chemical contamination: Presence of benzene
January 3, 2024DrugsFDA
TCP HRB ACQUISITON LLC recalls Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), packaged in 6 oz (170 g) aerosol cans, Di
Hazard: Chemical contamination: Presence of benzene
January 3, 2024DrugsFDA
TCP HRB ACQUISITON LLC recalls Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packaged in a) 4 oz. (113g) aerosol cans (UPC 008
Hazard: Chemical contamination: Presence of benzene
January 3, 2024DrugsFDA
Meta Herbal recalls Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 9930
Hazard: Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
January 3, 2024DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for
Hazard: CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
January 3, 2024DrugsFDA
AnazaoHealth Corporation recalls Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber Glass Vial, Rx only, AnazaoHealth, 7465 W.
Hazard: Presence of Particulate Matter.
January 3, 2024DrugsFDA
AnazaoHealth Corporation recalls B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxine HCI injection, 74/2/75/2/2 MG/ML, 30ML St
Hazard: Presence of Particulate Matter.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, M
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany,
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippan
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lan
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Ph
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contai
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., M
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switz
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt.
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc.,
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, In
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactu
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharma
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin P
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
January 3, 2024DrugsFDA
CARDINAL HEALTHCARE recalls Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx on
Hazard: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.