Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.5 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.25 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochoride Tablets 0.25 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole DihydrochlorideTablets 0.125 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Anastrozole Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
ANASTROZOLE Tablets
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
Senna
Reason Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported
Class II · Moderate risk Terminated
Bevacizumab 2.5 mg/0.1 mL
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx…
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 at the manufacturer
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx…
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 at the manufacturer
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 50 mg 90 film coated 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 at the manufacturer
Class II · Moderate risk Terminated
Losartan Potassium Tablets USP 100 mg 90 film coated 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 at the manufacturer
Class II · Moderate risk Terminated
Losartan Potassium 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 at the manufacturer
Class II · Moderate risk Terminated
Articaine DENTAL
Reason Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.
Class II · Moderate risk Terminated
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr
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 Himasal Natural Nasal Saline Solution with Himalayan Salt
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
CVS Health Children's Nasal Saline Drops With Himalayan Salt…
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 Organic…
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
CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief…
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 Cough & Chest Congestion DM
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
CVS Health Children's Allergy Relief Liquid Medication…
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 Pain & Fever Oral Solution Acetaminophen 160 mg/5 mL
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 Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.