Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Alcohol Free Foaming Hand Sanitizer
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
deb stoko
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
Irbesartan Bulk Active Pharmaceutical Ingredient.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk
Ortho-Novum 7/7/7
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Ortho-Novum 1/35
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Catapres .2
Failed Dissolution Specifications: OOS resultsduring routine stability testing
Class II · Moderate risk
children's allergy relief
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
children's allergy
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
Children's 24 Hour Allergy
Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk
Phenylephrine 30 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Phenylephrine 25 mg added to NS 250 mL Bag
Lack of assurance of sterility
Class II · Moderate risk
Hydromorphone
Lack of assurance of sterility
Class II · Moderate risk
Fentanyl (10 mcg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Morphine (1 mg/mL)
Lack of assurance of sterility
Class II · Moderate risk
Metoprolol Succinate Extended Release Tablets
Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Class II · Moderate risk
GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle
Presence of Particulate Matter: Crystalline particles were noticed by manufacturer at the 24 month clarity testing.
Class II · Moderate risk
Testosterone 200 mg/Anastrozole 20 mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 87.5mg pellet
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone 50mg pellet
Lack of Assurance of Sterility