Class II · Moderate risk Terminated
Ampicillin for Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Class II · Moderate risk Terminated
buPROPrion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class II · Moderate risk Terminated
Heparin Sodium
Reason Subpotent: Low anti-factor IIa Potency.
Class II · Moderate risk Terminated
Buprenorphine Sublingual Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Famotidine Tablets
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Class II · Moderate risk Terminated
LORazepam Injection
Reason CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Class II · Moderate risk Terminated
HyperLyte CR Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
HyperLyte CR Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Lidocaine 2% HCl Inj
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Potassium Acetate Injection
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Sodium Phosphates Injection 4 mEq/3 mMol/mL
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
Msa 7.84% Msg 8.56%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vasopressin 50 units added to 0.9% sodium chloride 50 mL*
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vasopressin 40 units added to 0.9% sodium chloride 100 mL*
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
vasopressin 20 units added to 0.9% sodium chloride 100 mL*
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
heparin added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
NORepinephrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
NORepinephrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
NORepinephrine added to dextrose 5%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
EPINEPHrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
tromethamine 0.3 Molar
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
oxyTOCIN 40 units added to 0.9% sodium chloride 1
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
heparin added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.