Class II · Moderate risk Terminated
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Ortho-Novum 7/7/7
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk Terminated
Ortho-Novum 1/35
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk Terminated
Catapres .2
Reason Failed Dissolution Specifications: OOS resultsduring routine stability testing
Class II · Moderate risk Terminated
children's allergy relief
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk Terminated
children's allergy
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk Terminated
Children's 24 Hour Allergy
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk Terminated
Phenylephrine 30 mg added to NS 250 mL Bag
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Phenylephrine 25 mg added to NS 250 mL Bag
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Hydromorphone
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Fentanyl
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Morphine
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Metoprolol Succinate Extended Release Tablets
Reason Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class II · Moderate risk Terminated
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Reason Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II · Moderate risk Terminated
Testosterone 200 mg/Anastrozole 20 mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 87.5mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 50mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 37.5 mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 25 mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 200mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 12.5mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Testosterone 100mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol 6 mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol 25mg pellet
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Estradiol 18mg pellet
Reason Lack of Assurance of Sterility