Class II · Moderate risk
Morphine Sulfate Oral Solution
Defective container: Oral solution leaking from container.
FDA Drug Recalls
1,134 recalls, newest first
Class II · Moderate risk
Neut Sodium Bicarbonate 4%
Lack of Sterility Assurance
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Sterility Assurance
Class II · Moderate risk
8.4% Sodium Bicarbonate Inj.
Lack of Sterility Assurance
Class II · Moderate risk
Potassium Phosphates Inj.
Lack of Sterility Assurance
Class II · Moderate risk
CVS Health Baby Eczema Moisturizing Cream
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Class III · Low risk
Gaviscon (Alumina & Magnesium Trisilicate)
Superpotent Drug: high out-of-specification result for magnesium.
Class II · Moderate risk
Magnesium Citrate Saline Laxative Cherry Flavored
Presence of foreign substance: glass particle
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin
Subpotent Drug: found to be below the specification for labeled assay.
Class I · High risk
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Subpotent Drug: found to be below the specification for labeled assay.
Class II · Moderate risk
VenomX
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StaphWash+Plus+ Skin Protectant
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
StingMed Insect bites Skin Protectant. Zinc acetate
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Diabecline brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
TetraStem brand Topical Ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class II · Moderate risk
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I · High risk
Andropharm M1 Alpha
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk
Andropharm Sten Z
Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class I · High risk
EliquisTablets 5mg
Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.