Class II · Moderate risk
Mometasone Furoate Topical Solution
CGMP Deviaitons
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.
14,543 recalls, newest first.
Class II · Moderate risk
Thumbs Up 7 Blue 69K
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk
ViCTOZA (liraglutide)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class II · Moderate risk
Saxenda (liraglutide)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class II · Moderate risk
OZEMPIC (semaglutide)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class II · Moderate risk
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
BD ChloraPrep Clear
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class II · Moderate risk
Neomycin Sulfate Tablets
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Class II · Moderate risk
Omeprazole Delayed Release Capsules
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk
Enalapril Maleate Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Brompheniramine Maleate
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
CYANOCOBAL Injection 1000MCG/ML 25X1ML
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Corgard (nadolol tablets, USP)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
HALOPERIDOL TABLETS 20mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Amantadine Hydrochloride Tablets 100 mg 100-count bottle
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Briviact (brivaracetam)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
VIMPAT (lacosamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
VIMPAT (lacosamide)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
INTEGRA 325/40/3mg 90-count bottle
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Tramadol Hydrochloride Tablets USP 100mg
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Folivane-Plus with Ascorbic Acid Precursors Iron/Folic…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only
CGMP Deviations: Intermittent exposure to temperature excursion during storage.