Class II · Moderate risk
Calcium chloride 10%
Lack of Assurance of Sterility.
FDA Drug Recalls
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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.
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class II · Moderate risk
Povidone Iodine
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
Procrit Epoetin Alfa 40
Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.
Class II · Moderate risk
Vitamin A&D Ointment
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.