Class II · Moderate risk
Hand-I-San
CGMP Deviations: sterile water not used for production
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Rubbing Alcohol
CGMP Deviations: sterile water not used for production
Class II · Moderate risk
Empower Pharmacy
Lack of Assurance of Sterility
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 III · Low risk
Methotrexate Tablets
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
Failed Dissolution Specifications: below specification results
Class II · Moderate risk
Gabapentin Tablets
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
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 III · Low risk
Acetaminophen
Label mix-up: Carton incorrectly labeled.
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
Clonazepam Orally Disintegrating Tablets
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
Nitrofurantoin Capsules
Failed Dissolution Specifications
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
Peg-3350
Defective container: potential for non-sealed pouches which can lead to product leakage.
Class III · Low risk
Micafungin for injection
Cross contamination with other products
Class III · Low risk
Micafungin for injection
Cross contamination with other products