Class II · Moderate risk
Mic 25/50/50
Lack of Assurance of Sterility.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
L-Glutamine 100mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Magnesium Chloride 200mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Methylcobalamin 10mg
Lack of Assurance of Sterility.
Class II · Moderate risk
B-Complex
Lack of Assurance of Sterility.
Class II · Moderate risk
Calcium chloride 10%
Lack of Assurance of Sterility.
Class II · Moderate risk
G.A.C 25/100/250mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Mannitol 20%
Lack of Assurance of Sterility.
Class II · Moderate risk
Methylcobalamin 10mg
Lack of Assurance of Sterility.
Class II · Moderate risk
PF-Glutathione 200mg/ml
Lack of Assurance of Sterility.
Class II · Moderate risk
Ketorolac Tromethamine Injection
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Class III · Low risk
Phentermine Capsules
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension
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
Succinylcholine chloride 100 mg in 5 mL syringe
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
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL
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
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL
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
Norepinephrine 8 mg in dextrose 5% 250 mL
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
Neostigmine Methylsulfate 5 mg/5 mL
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
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA
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
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA
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
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL
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
Amiodarone 900 mg in dextrose 5% 500 mL
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
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL
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
Neostigmine Methylsulfate
Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class I · High risk
Pravastatin Sodium Tablets
Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.