Class II · Moderate risk Terminated
Ibuprofen Tablets
Reason Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate Oral Solution
Reason Defective container: Oral solution leaking from container.
Class II · Moderate risk Terminated
Neut Sodium Bicarbonate 4%
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Succinylcholine Chloride Injection
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
8.4% Sodium Bicarbonate Inj.
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
Potassium Phosphates Inj.
Reason Lack of Sterility Assurance
Class II · Moderate risk Terminated
CVS Health Baby Eczema Moisturizing Cream
Reason Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Class II · Moderate risk Terminated
Magnesium Citrate Saline Laxative Cherry Flavored
Reason Presence of foreign substance: glass particle
Class II · Moderate risk Terminated
NitroGlycerin
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj
Reason Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
Class II · Moderate risk Terminated
VenomX
Reason 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 Terminated
StaphWash+Plus+ Skin Protectant
Reason 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 Terminated
StingMed Insect bites Skin Protectant. Zinc acetate
Reason 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 Terminated
Diabecline brand Topical Ointment First Aid Antibiotic
Reason 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 Terminated
TetraStem brand Topical Ointment First Aid Antibiotic
Reason 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 Terminated
Tetracycline-ABC Brand Topical ointment First Aid Antibiotic
Reason 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 Terminated
NasalCrom
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class II · Moderate risk Terminated
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%
Reason Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.
Class II · Moderate risk Terminated
Chlorhexidine Gluconate 0.12% Oral Rinse
Reason CGMP Deviations
Class II · Moderate risk Terminated
Doxycycline Hyclate USP
Reason Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.