Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
FDA Drug Recalls
354 recalls, newest first
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk
Testosterone Gel
Superpotent Drug
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Class II · Moderate risk
Progesterone Injection
Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Class I · High risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter
Class II · Moderate risk
Ciprofloxacin ophthalmic solution USP
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
Glenmark
CGMP Deviations
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective container; yellow colored spike from cap lodged in the nozzle
Class I · High risk
Umary Acido Hialuronico
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Umary Acido Hialuronico
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Class I · High risk
Gold Hard Steel Plus Liquid
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Class I · High risk
Healthy Living Acetaminophen
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Class I · High risk
Acetaminophen Injection
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
Lidocaine HCL Injection
Subpotent Drug: reduced efficacy for epinephrine
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class III · Low risk
Verapamil Hydrochloride Injection
Cross contamination with other products.
Class II · Moderate risk
Decitabine for Injection 50mg per vial
CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.
Class II · Moderate risk
Pravastatin Sodium Tablets
Failed Dissolution Specifications: results below specifications