May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Simvastatin USP, 10 mg, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pha
Hazard: CGMP deviations.
May 10, 2023DrugsFDA
Bryant Ranch Prepack, Inc. recalls Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per carton (63629-8755-1), Rx only, each patch
Hazard: Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
May 3, 2023DrugsFDA
Sun Pharmaceutical Industries Ltd. recalls Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutane
Hazard: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
May 3, 2023DrugsFDA
SCA Pharmaceuticals recalls Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT
Hazard: Subpotent Drug: Out of specification results for low potency was obtained.
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indian
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
Northwind Pharmaceuticals LLC recalls Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapo
Hazard: CGMP Deviations
May 3, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: Du
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
May 3, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
May 3, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
May 3, 2023DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured
Hazard: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
May 3, 2023DrugsFDA
Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter He
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
May 3, 2023DrugsFDA
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
May 3, 2023DrugsFDA
Wellness BioSciences recalls CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Hazard: Marketed Without an Approved NDA/ANDA
May 3, 2023DrugsFDA
Methapharm Inc recalls Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methap
Hazard: CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
April 26, 2023DrugsFDA
Ascend Laboratories, LLC recalls Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA
Hazard: Out of specification (OOS) for Spectroscopic Identification test by IR.
April 26, 2023DrugsFDA
Pharmacy Plus, Inc. dba Vital Care Compounder recalls C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS
Hazard: Lack of assurance of sterility.
April 26, 2023DrugsFDA
Pharma Nobis LLC recalls Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: C
Hazard: CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
April 26, 2023DrugsFDA
Amerisource Health Services LLC recalls Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by
Hazard: Failed Dissolution Specifications: Out of specification dissolution results above specified values.
April 19, 2023DrugsFDA
Focus Health Group Inc recalls Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/mL, Rx Only, Focus Health Group, Manufacture
Hazard: Labeling; Incorrect NDC number on outer carton of product.
April 19, 2023DrugsFDA
Pfizer Inc. recalls MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned su
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
April 19, 2023DrugsFDA
Pine Pharmaceuticals, LLC recalls Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in indiv
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
April 19, 2023DrugsFDA
Hetero USA Inc recalls Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceutic
Hazard: CGMP Deviations: Discoloration
April 19, 2023DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packag
Hazard: Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
April 12, 2023DrugsFDA
Accord Healthcare, Inc. recalls Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutan
Hazard: Sub-potent drug: assay test result below specifications at 9-month timepoint.