Class II · Moderate risk Terminated
Thumbs Up 7 Red 70K
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Cefprozil for Oral Suspension USP
Reason Superpotent Drug
Class II · Moderate risk Terminated
PremierZen Black 5000 capsules
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Class II · Moderate risk Terminated
Mometasone Furoate Topical Solution
Reason CGMP Deviaitons
Class II · Moderate risk Terminated
Thumbs Up 7 Blue 69K
Reason Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Class II · Moderate risk Terminated
ViCTOZA
Reason 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 Terminated
Saxenda
Reason 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 Terminated
Ozempic
Reason 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 Terminated
ChloraPrep With Tint 2% w/v chlorhexidine gluconate
Reason 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 Terminated
ChloraPrep One-Step 2% w/v chlorhexidine gluconate
Reason 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 Terminated
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Reason 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 Terminated
BD ChloraPrep Clear
Reason 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 Terminated
Neomycin Sulfate Tablets
Reason Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Class II · Moderate risk Terminated
Omeprazole Delayed Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Class II · Moderate risk Terminated
Enalapril Maleate Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Brompheniramine Maleate
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
CYANOCOBAL Injection 1000MCG/ML 25X1ML
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Corgard
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
HALOPERIDOL TABLETS 20mg
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Amantadine Hydrochloride Tablets 100 mg 100-count bottle
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Briviact
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vimpat
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Vimpat
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
INTEGRA 325/40/3mg 90-count bottle
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.