Class II · Moderate risk
TRP Natural Eyes Dryness Relief
Lack of Assurance of Sterility
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
TRP Eye Twitching Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Blur Relief
Lack of Assurance of Sterility
Class II · Moderate risk
TRP Natural Eyes Allergy Eyes Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Tobramycin for Injection
Failed Stability Specification: Water determination was found not complying with specification.
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Nicardipine Hydrochloride Injection
Failed Impurities/Degradation Specifications: Out of specification for organic impurities
Class II · Moderate risk
Methylprednisolone acetate Injectable Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Lidocaine HCL 1%
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin 5mg/ml
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Class II · Moderate risk
Moxifloxacin PF
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
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
Broncochem Cold & Tea
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk
Broncochem Cold & Flu Syrup Kids
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP
CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
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.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray USP 50mcg
CGMP Deviations: potential presence of Burkholderia cepacia complex
Class II · Moderate risk
HydrALAZINE Hydrochloride Tablets
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.