Class II · Moderate risk
MORphine 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Midazolam 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
MAGnesium 4gm in NS 100 mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
HYDROmorphone 1 mg/mL
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
Heparin 25
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
fentaNYL (10 mcg per mL)
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
EPINEPHrine
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ePHEDrine 50mg
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk
0.2% ROPivacaine - OnQ Pump
Lack of Assurance of Sterility: Potential leakage of bags.
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Atorvastatin Calcium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Monsel's Solution
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class III · Low risk
TESTOSTERONE 200 mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class III · Low risk
ESTRADIOL 20mg PELLET
Labeling: Incorrect or Missing Lot and/or Exp Date.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Superpotent Drug: High out of specification assay value results for potency.
Class III · Low risk
Maxzide-25
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class II · Moderate risk
Kit for the Preparation of Technetium Tc99m Medronate
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Superpotent and Subpotent
Class I · High risk
Naloxone Hydrochloride Injection
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
Class II · Moderate risk
5% Dextrose Injection
Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of assurance of sterility: Bags have potential to leak.