Class II · Moderate risk Terminated
Bevacizumab Prefilled 30g and 31 gram 1.25mg/0.05mL Syringes
Reason Lack of Assurance of Sterility.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Fluorescein Sodium
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Sodium Bicarbonate 8.4%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Lidocaine Ophthalmic Gel 3.5%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Mic 25/50/50
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
L-Glutamine 100mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Magnesium Chloride 200mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Methylcobalamin 10mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
B-Complex
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Calcium chloride 10%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
G.A.C 25/100/250mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Mannitol 20%
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Methylcobalamin 10mg
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
PF-Glutathione 200mg/ml
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Class II · Moderate risk Terminated
Amoxicillin and Clavulanate Potassium for Oral Suspension
Reason Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Class II · Moderate risk Terminated
Succinylcholine chloride 100 mg in 5 mL syringe
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Norepinephrine 8 mg in dextrose 5% 250 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Neostigmine Methylsulfate 5 mg/5 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.