Class II · Moderate risk
Ranitidine Tablets
CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
1,586 recalls · Class II, newest first
Class II · Moderate risk
Dr. Reddy's: Ranitidine Capsules 150 mg
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Children's Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk
Estradiol tablets
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Class II · Moderate risk
Vivitrol (naltrexone for extended-release injectable suspension)
Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Class II · Moderate risk
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Equate Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Equate Maximum Strength Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Pioglitazone Hydrochloride Tablets USP 15 mg
Superpotent
Class II · Moderate risk
DrKids Himasal Natural Nasal Saline Solution
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
DrKids Children's Natural Cough Syrup English Ivy Leaf
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Prednisolone Sodium Phosphate Oral Solution
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx…
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk
Phenylephrine Hydrochloride Ophthalmic Solution
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Class II · Moderate risk
Dextroamphetamine Sacharate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class II · Moderate risk
Losartan Potassium/ Hydrochlorothiazide Tablets
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.