October 9, 2024DrugsFDA
Supercore Products Group Inc. recalls Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199
Hazard: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
October 9, 2024DrugsFDA
Supercore Products Group Inc. recalls Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Hazard: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
October 9, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 g
Hazard: Defective Container: Firm received complaints of broken tube at the seal.
October 9, 2024DrugsFDA
Nivagen Pharmaceuticals Inc recalls Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, In
Hazard: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
October 2, 2024DrugsFDA
Ascend Laboratories, LLC recalls Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratori
Hazard: Failed Dissolution Specifications
October 2, 2024DrugsFDA
EnviroServe Chemicals Inc. recalls EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603
Hazard: CGMP deviations
October 2, 2024DrugsFDA
Guru Inc. recalls Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370
Hazard: Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
October 2, 2024DrugsFDA
AbbVie Inc. recalls Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Dis
Hazard: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
October 2, 2024DrugsFDA
AbbVie Inc. recalls Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distribut
Hazard: Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
October 2, 2024DrugsFDA
Empower Pharmacy recalls Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Comp
Hazard: Lack of Assurance of Sterility
October 2, 2024DrugsFDA
Vivier Pharma, Inc. recalls Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier
Hazard: Microbial Contamination of Non-Sterile Product
October 2, 2024DrugsFDA
Mckesson Medical-Surgical Inc. Corporate Office recalls Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208
Hazard: Temperature abuse: Products exposed to improper temperature above drug label specifications.
October 2, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513,
Hazard: Subpotent Drug
September 25, 2024DrugsFDA
Rubicon Research Private Limited recalls AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ,
Hazard: Discoloration
September 18, 2024DrugsFDA
Elevate Oral Care recalls Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral C
Hazard: LABELING: LABEL MIX-UP.
September 18, 2024DrugsFDA
PREQUEL SKIN recalls BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELE
Hazard: Microbial contamination of non-sterile Products -
September 11, 2024DrugsFDA
ProRx LLC recalls TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-70
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341,
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, N
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
ProRx LLC recalls Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-0
Hazard: Lack of Assurance of Sterility
September 11, 2024DrugsFDA
Baxter Healthcare Corporation recalls Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Singl
Hazard: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
September 4, 2024DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Bal
Hazard: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
September 4, 2024DrugsFDA
Preferred Pharmaceuticals, Inc. recalls Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisi
Hazard: Failed Impurities/Degradation Specifications - at 18-month Stability testing
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
September 4, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count b
Hazard: Failed Dissolution Specifications: below specification results