Class II · Moderate risk Terminated
del Nido Cardioplegia Solution
Reason Lack of Assurance of Sterility; bags have potential to leak
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Amino Acid Injection 50 g/1000 mL
Reason Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9%…
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9%…
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
PF-Fentanyl Citrate
Reason GMP Deviations: potential glass contamination
Class II · Moderate risk Terminated
Leucovorin Calcium Injection
Reason Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk Terminated
Rifampin for Injection
Reason Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.
Class II · Moderate risk Terminated
10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection
Reason Lack of Assurance of Sterility: Bag has the potential to leak.
Class II · Moderate risk Terminated
Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL…
Reason Lack of sterility assurance.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Dr. Reddy's Ranitidine Capsules
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets 75 mg
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.
Class II · Moderate risk Completed
Ranitidine Tablets
Reason CGMP Deviations: Presence of NDMA impurity detected in product.