Class II · Moderate risk Terminated
NORepiNEPHrine 8 mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
MORphine 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Midazolam 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
MAGnesium 4gm in NS 100 mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
HYDROmorphone 1 mg/mL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Heparin 25
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
fentaNYL
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ePHEDrine 50mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
0.2% ROPivacaine - OnQ Pump
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Monsel's Solution
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason Superpotent Drug: High out of specification assay value results for potency.
Class II · Moderate risk Terminated
Kit for the Preparation of Technetium Tc99m Medronate
Reason Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride
Reason Superpotent and Subpotent
Class II · Moderate risk Terminated
5% Dextrose Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
0.45% Sodium Chloride Injection
Reason Lack of assurance of sterility: Bags have potential to leak.
Class II · Moderate risk Terminated
Fluticasone propionate Nasal Spray
Reason Presence of foreign substance: glass particles
Class II · Moderate risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
Class II · Moderate risk Terminated
Acne Shave 3 Step Shaving System
Reason CGMP Deviations: products may be contaminated with bacteria.