Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Ongoing
Semaglutide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Nicotinamide adenine dinucleotide
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LX Bioboost Plus
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
LL Bioboost Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
CJC-1295 Injectable
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Methylcobalamin Injectable
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Ezetimibe and Simvastatin Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules
Reason cGMP deviations
Class II · Moderate risk Ongoing
Theophylline
Reason OOS results reported for the Dissolution (by UV) test.
Class II · Moderate risk Ongoing
BD ChloraPrep Clear
Reason Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Class II · Moderate risk Ongoing
Airsupra
Reason Defective delivery system
Class II · Moderate risk Ongoing
Celecoxib Capsules
Reason Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class II · Moderate risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk Ongoing
Esomeprazole Magnesium for Delayed-Release Oral Suspension
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Class II · Moderate risk Ongoing
Chlorthalidone Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
Celecoxib Capsules
Reason Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class II · Moderate risk Ongoing
Phentermine Hydrochloride Capsules
Reason cGMP deviations
Class II · Moderate risk Ongoing
Indomethacin Extended-Release Capsules USP
Reason cGMP deviations
Class II · Moderate risk Ongoing
Bromfenac Ophthalmic Solution 0.09%
Reason Failed Impurities/Degradation Specifications
Class I · High risk Ongoing
Endurance Boost With Horny Goat Weed
Reason Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and Propoxyphenylsildenafil (a sildenafil analogue).
Class II · Moderate risk Ongoing
Testosterone Cypionate Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg BLUNT
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Class II · Moderate risk Ongoing
TESTOSTERONE PELLET 200 mg BLUNT
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.