Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Completed
Dr. Reddy's: Ranitidine Capsules 150 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Children's Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Ibuprofen Oral Suspension USP
Reason Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
Class II · Moderate risk Terminated
Estradiol tablets
Reason 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 Terminated
Vivitrol
Reason 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 Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Equate Maximum Strength Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Equate Maximum Strength Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Completed
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Pioglitazone Hydrochloride Tablets USP 15 mg
Reason Superpotent
Class II · Moderate risk Terminated
DrKids Himasal Natural Nasal Saline Solution
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
DrKids Children's Natural Cough Syrup English Ivy Leaf
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk Terminated
Prednisolone Sodium Phosphate Oral Solution
Reason Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx…
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Class II · Moderate risk Terminated
Phenylephrine Hydrochloride Ophthalmic Solution
Reason 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 Terminated
Dextroamphetamine Sacharate
Reason Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Class II · Moderate risk Ongoing
Losartan Potassium/ Hydrochlorothiazide Tablets
Reason 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.