Class II · Moderate risk Terminated
Lyophilized Chorionic Gonadotropin 11
Reason Lack of Sterility Assurance.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
del Nido Cardioplegia Solution
Reason Lack of Assurance of Sterility; bags have potential to leak
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 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 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.