Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lorazepam Injection
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
buPROPrion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications; during stability testing
Class II · Moderate risk
Heparin Sodium
Subpotent: Low anti-factor IIa Potency.
Class II · Moderate risk
Buprenorphine Sublingual Tablets
CGMP Deviations
Class II · Moderate risk
Famotidine Tablets
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
LORazepam Injection
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
HyperLyte CR Injection
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
HyperLyte CR Injection
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
Lidocaine 2% HCl Inj
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
Potassium Acetate Injection
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
Sodium Phosphates Injection 4 mEq/3 mMol/mL
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
Msa 7.84% Msg 8.56%
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
vasopressin 50 units added to 0.9% sodium chloride 50 mL*
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
vasopressin 40 units added to 0.9% sodium chloride 100 mL*
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
vasopressin 20 units added to 0.9% sodium chloride 100 mL*
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
heparin added to 0.9% sodium chloride
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
NORepinephrine added to 0.9% sodium chloride
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
NORepinephrine added to 0.9% sodium chloride
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
NORepinephrine added to dextrose 5%
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
EPINEPHrine added to 0.9% sodium chloride
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.