Class II · Moderate risk
First Aid Only BZK Antiseptic Towelette
CGMP Deviations
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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 I · High risk
Udenyca
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
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
Class III · Low risk
Fluocinolone Acetonide Solution Topical Solution USP
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D.
Class II · Moderate risk
Ondansetron Orally Disintegrating Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.