Class II · Moderate risk
Mic 25/50/50
Lack of Assurance of Sterility.
FDA drug recalls in 2017
Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 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.