July 10, 2024DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Via
Hazard: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
July 10, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500
Hazard: Failed Impurities/Degradation Specifications: Related Substances
July 10, 2024DrugsFDA
Accord Healthcare, Inc. recalls Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord
Hazard: Subpotent drug: out of specification results
July 10, 2024DrugsFDA
Trigen Laboratories recalls Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen
Hazard: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle,
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Little Moon Essentials LLC recalls Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC
Hazard: CGMP deviations
July 10, 2024DrugsFDA
Medisca Inc. recalls Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12
Hazard: CGMP Deviations and Presence of Particulate Matter: Glass
July 3, 2024DrugsFDA
Neilmed Pharmaceuticals Inc recalls SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12
Hazard: Sub-potent Drug
July 3, 2024DrugsFDA
Golden State Medical Supply Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottle
Hazard: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
July 3, 2024DrugsFDA
PACIRA PHARMACEUTICALS INC recalls Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pa
Hazard: Failed Dissolution Specifications - did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C
July 3, 2024DrugsFDA
Contract Pharmacal Corporation recalls Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park
Hazard: Discoloration: Brownish tablets
July 3, 2024DrugsFDA
Pfizer Inc. recalls Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Lu
Hazard: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
July 3, 2024DrugsFDA
Pfizer Inc. recalls Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock
Hazard: Lack of Assurance of Sterility-The potential for incomplete crimp seals.
July 3, 2024DrugsFDA
Coast Quality Pharmacy, LLC dba Anazao Health recalls Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth,
Hazard: Presence of Foreign Substance; Broken metal piece found embedded in tablet.
June 26, 2024DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Mar
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
June 26, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canad
Hazard: Subpotent Drug
June 26, 2024DrugsFDA
Consumer Product Partners, LLC recalls Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822
Hazard: Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum jelly with Lavendar and Chamomile
June 26, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: L
Hazard: Failed Content Uniformity Specifications
June 26, 2024DrugsFDA
MexHealth LLC recalls OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturista
Hazard: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and methocarbamol,
June 26, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte
Hazard: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
June 26, 2024DrugsFDA
Eugia US LLC recalls Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E.
Hazard: Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
June 26, 2024DrugsFDA
Eugia US LLC recalls Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by
Hazard: Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
June 19, 2024DrugsFDA
Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceu
Hazard: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
June 19, 2024DrugsFDA
Sagent Pharmaceuticals recalls Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceutic
Hazard: Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.