Class II · Moderate risk
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
cGMP violations
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
Phenylephrine HCl 0.9% Sodium Chloride Injection USP
CGMP violations
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Ryaltris (olopatadine hydrochloride and mometasone fluorate)
Defective Delivery System: The dip tube is clogged causing the spray not to work.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Class II · Moderate risk
Pluvicto
CGMP deviations
Class II · Moderate risk
EnviroClean Hand Sanitizer Gel
CGMP deviations
Class II · Moderate risk
Refresh LACRI-LUBE
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Refresh P.M.
Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.
Class II · Moderate risk
Proparacaine Hydrochloride Ophthalmic Solution
Temperature abuse: Products exposed to improper temperature above drug label specifications.
Class II · Moderate risk
Hylenex recombinant
cGMP Deviations: Temperature excursion
Class II · Moderate risk
First Aid Antiseptic Ointment
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Class II · Moderate risk
Pyridoxine HCL
Lack of Assurance of Sterility
Class II · Moderate risk
Mycophenolic Acid Delayed-Release Tablets USP
Failed Dissolution Specifications
Class II · Moderate risk
Vivier Sheer SPF 30 Mineral With Antioxidants
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Mupirocin Ointment
Subpotent Drug
Class II · Moderate risk
Barrier Therapy Skin Protectant Cream
Microbial contamination of non-sterile Products -
Class II · Moderate risk
TIRZEPATIDE 60 mg/3mL
Lack of Assurance of Sterility
Class II · Moderate risk
TIRZEPATIDE 20 mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 10mg/4mL
Lack of Assurance of Sterility
Class II · Moderate risk
SEMAGLUTIDE 5mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 2 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide
Lack of Assurance of Sterility
Class II · Moderate risk
Cefixime for Oral Suspension USP
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.