DrugMar 8, 2023
Tadalafil Tablets, USP, 2.5 mg recall — FDA D-0414-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
March 2023 recalls — page 30
These records include useful source details for the selected month.
DrugMar 8, 2023
Accord Healthcare Finasteride Tablets USP 1 mg, 90-count bottle, Keeps recall — FDA D-0391-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Simvastatin Tablets USP 40 mg recall — FDA D-0411-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Aripiprazole Tablets, USP 15 mg recall — FDA D-0368-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Phenylephrine HCl Injection, USP, 1 mg/10 mL recall — FDA D-0359-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
Glimepiride Tablets USP, 1 mg recall — FDA D-0393-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Aripiprazole Tablets, USP 10 mg recall — FDA D-0367-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Nephron Sterile Compounding Center Norepinephrine Bitartrate in 0.9% Sodium Chloride recall — FDA D-0358-2023
Lack of Assurance of Sterility
Class IIFDA: TerminatedNephron Sterile Compounding Center LLC
DrugMar 8, 2023
Tadalafil Tablets, USP 10 mg recall — FDA D-0416-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials recall — FDA D-0398-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Pravastatin Sodium Tablets USP, 80 mg recall — FDA D-0424-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP, 10 mg* recall — FDA D-0371-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP, 5 mg recall — FDA D-0376-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle recall — FDA D-0425-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton recall — FDA D-0419-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 40 mg* recall — FDA D-0373-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Volt Candy Wholesale Club PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance recall — FDA D-0453-2023
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of…
Class IFDA: TerminatedVolt Candy Wholesale Club
DrugMar 8, 2023
DuPont Nutrition USA BD-102 NF, Microcrystalline Cellulose, NF, Ph recall — FDA D-0352-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIFDA: TerminatedDuPont Nutrition USA, Inc.
DrugMar 8, 2023
Montelukast Sodium Tablets, USP, 10 mg* recall — FDA D-0400-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle recall — FDA D-0379-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Atorvastatin Calcium Tablets USP 80 mg* recall — FDA D-0374-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Levothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle recall — FDA D-0353-2023
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class IIFDA: TerminatedAlvogen, Inc.
DrugMar 8, 2023
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle recall — FDA D-0384-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Class IIFDA: TerminatedAccord Healthcare, Inc.
DrugMar 8, 2023
Gabapentin Tablets, USP 600 mg, 500 tablets per bottle recall — FDA D-0354-2023
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class IIIFDA: TerminatedSciegen Pharmaceuticals Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.