Class II · Moderate risk Terminated
Gabapentin Tablets
Reason Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Progesterone Injection
Reason Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class I · High risk Ongoing
0.9% Sodium Chloride Injection USP
Reason Presence of Particulate Matter
Class II · Moderate risk Ongoing
Ciprofloxacin ophthalmic solution USP
Reason Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Class II · Moderate risk Ongoing
Glenmark
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Timolol Maleate Ophthalmic Solution USP
Reason Defective container; yellow colored spike from cap lodged in the nozzle
Class III · Low risk Terminated
Acetaminophen
Reason Label mix-up: Carton incorrectly labeled.
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Umary Acido Hialuronico
Reason Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk Ongoing
Gold Hard Steel Plus Liquid
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Reason Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk Ongoing
Healthy Living Acetaminophen
Reason Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class I · High risk Terminated
Clonazepam Orally Disintegrating Tablets
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules
Reason Failed Dissolution Specifications
Class I · High risk Ongoing
Acetaminophen Injection
Reason Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Class II · Moderate risk Ongoing
Lidocaine HCL Injection
Reason Subpotent Drug: reduced efficacy for epinephrine
Class III · Low risk Terminated
Peg-3350
Reason Defective container: potential for non-sealed pouches which can lead to product leakage.
Class III · Low risk Completed
Micafungin for injection
Reason Cross contamination with other products
Class III · Low risk Completed
Micafungin for injection
Reason Cross contamination with other products
Class III · Low risk Ongoing
Verapamil Hydrochloride Injection
Reason Cross contamination with other products.
Class III · Low risk Ongoing
Verapamil Hydrochloride Injection
Reason Cross contamination with other products.
Class II · Moderate risk Ongoing
Decitabine for Injection 50mg per vial
Reason CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk Ongoing
Pravastatin Sodium Tablets
Reason Failed Dissolution Specifications: results below specifications
Class II · Moderate risk Ongoing
Fludrocortisone Acetate Tablets
Reason Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
Class II · Moderate risk Terminated
Cyanocobalamin Injection
Reason Presence of particulate matter: glass