Class II · Moderate risk
Timolol Maleate Ophthalmic Solution
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Cefdinir for Oral Suspension USP 125 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Cefdinir for Oral Suspension USP 250 mg/5 mL
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Class II · Moderate risk
Eylea
Lack of Assurance of Sterility: Complaints of syringe breakage
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
minolira (minocycline hydrochloride)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Cloderm (clocortolone pivalate)
CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk
Eyesaline
CGMP Deviations
Class II · Moderate risk
Lansoprazole Delayed-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk
Lactated Ringer's Injection USP
Lack of assurance of sterility: bags have the potential to leak..
Class II · Moderate risk
Rifampin Capsules USP
Subpotent Drug
Class II · Moderate risk
VCF Vaginal Contraceptive Film
cGMP Diviations
Class II · Moderate risk
Tri-Lo-Sprintec
Failed Dissolution Specifications
Class II · Moderate risk
Potassium Chloride for Injection Concentrate USP
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class II · Moderate risk
Betimol (timolol ophthalmic solution)
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Class II · Moderate risk
PROBLEND Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven Hand Sanitizer Gel
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
7 Eleven FOR GAS ISLAND USE ONLY
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND E3 Foaming Hand Sanitizer
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II · Moderate risk
CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide)
CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.
Class II · Moderate risk
Telmisartan Tablets
Failed Stability Specifications: Out of specification for blend uniformity.