December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, I
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron,
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
Fagron, Inc recalls NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, In
Hazard: Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
December 27, 2023DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case
Hazard: Failed Content Uniformity Specifications
December 27, 2023DrugsFDA
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 0770
Hazard: CGMP Deviations: Stability data does not support expiry date.
December 27, 2023DrugsFDA
Insight Pharmaceuticals Corporation recalls TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: In
Hazard: Chemical Contamination; presence of benzene.
December 20, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. C
Hazard: Failed Impurities/Degradation Specifications
December 20, 2023DrugsFDA
Siegfried Barbera, SL recalls Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Val
Hazard: Failed Dissolution Specifications
December 20, 2023DrugsFDA
Lupin Pharmaceuticals Inc. recalls Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD
Hazard: Failed Dissolution Specifications
December 13, 2023DrugsFDA
STAQ Pharma, Inc. recalls ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma In
Hazard: STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
December 13, 2023DrugsFDA
Baxter Healthcare Corporation recalls Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation
Hazard: Failed pH Specifications
December 13, 2023DrugsFDA
Novartis Pharmaceuticals Corporation recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM H
Hazard: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
December 13, 2023DrugsFDA
KINDER FARMS LLC recalls KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ
Hazard: Failed Impurities/Degradation Specifications
December 13, 2023DrugsFDA
KINDER FARMS LLC recalls KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (11
Hazard: Failed Impurities/Degradation Specifications
December 13, 2023DrugsFDA
Wells Pharma of Houston LLC recalls ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), Syringe, Rx only, Wells Ph
Hazard: Lack of assurance of sterility.
December 13, 2023DrugsFDA
Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop recalls LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL
Hazard: Product Mix-up: Incorrect Product Formulation
December 13, 2023DrugsFDA
Padagis US LLC recalls Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratori
Hazard: Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
December 13, 2023DrugsFDA
SUGARMDS LLC recalls Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 c
Hazard: MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
December 13, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical
Hazard: Failed Dissolution Specifications
December 6, 2023DrugsFDA
Botanical Be recalls Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44
Hazard: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
December 6, 2023DrugsFDA
Botanical Be recalls Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Co
Hazard: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
December 6, 2023DrugsFDA
Botanical Be recalls Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottles, Manufactured by: Plantas medicinales de
Hazard: Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
December 6, 2023DrugsFDA
Bayer Healthcare Pharmaceuticals Inc. recalls VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceutica
Hazard: Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
December 6, 2023DrugsFDA
Golden State Medical Supply Inc. recalls PAROXETINE tablets, USP, 40 mg, Packaged as a) 30-count bottle, NDC 60429-737-30; b) 90-count bottle NDC 60429-737-90;
Hazard: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Golden State Medical Supply Inc. recalls PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10;
Hazard: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Golden State Medical Supply Inc. recalls PAROXETINE tablets, USP, 10 mg, Packaged as a) 30-count bottle, NDC 60429-734-30; b) 90-count bottle NDC 60429-734-90;
Hazard: Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva Pharmaceutica
Hazard: OOS for viscosity
December 6, 2023DrugsFDA
VistaPharm LLC recalls Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for
Hazard: Failed Excipient Specifications: high content of ethylene glycol (EG)
December 6, 2023DrugsFDA
Fagron Compounding Services recalls Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottl
Hazard: Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
December 6, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, G
Hazard: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen