Class II · Moderate risk Terminated
Ketorolac Tromethamine Injection
Reason Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Phentermine Capsules
Reason 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 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.
Class II · Moderate risk Terminated
Amiodarone 900 mg in dextrose 5% 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
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 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
Reason Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class I · High risk Terminated
Pravastatin Sodium Tablets
Reason Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
Class III · Low risk Terminated
Quillivant XR methylphenidate HCl
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Quillivant XR methylphenidate HCl
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Povidone Iodine
Reason Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Class II · Moderate risk Terminated
Procrit Epoetin Alfa 40
Reason Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Class II · Moderate risk Terminated
Vitamin A&D Ointment
Reason Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Class III · Low risk Terminated
Phentermine HCL Capsules
Reason Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class I · High risk Terminated
Lorazepam Oral Concentrate
Reason Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
Class II · Moderate risk Terminated
Rugby Senexon Liquid Natural Vegetable Stimulant
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Rugby Aller-chlor
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
Class II · Moderate risk Terminated
Major Senna Syrup Natural Vegetable Laxative
Reason Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination