Class II · Moderate risk
Savannah Antibacterial Towelettes
CGMP Deviations
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
Max Packaging Antibacterial Towelette
CGMP Deviations
Class II · Moderate risk
1) BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelette
CGMP Deviations
Class II · Moderate risk
Dukal BZK Antiseptic Towelette
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
First Aid Only BZK Antiseptic Towelettes
CGMP Deviations
Class II · Moderate risk
Thyroid
Subpotent Drug
Class II · Moderate risk
methylprednisolone tablets
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Isotretinoin Capsules
Superpotent and Subpotent
Class II · Moderate risk
Furosemide Tablets
Presence of Foreign Substance
Class II · Moderate risk
Aq 120 Gfew
cGMP deviations.
Class II · Moderate risk
Lanreotide Injection
Presence of Particulate Matter.
Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gonio Eye Lubricant
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced…
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gel Hypromellose USP 0.3% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Tears Polyethylene Glycol 400 0.4% w/v
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets.
Class II · Moderate risk
Icosapent Ethyl capsules
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules