Class II · Moderate risk
CVS Health Baby Eczema Moisturizing Cream
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
FDA Drug Recalls
893 recalls · Class II, newest first
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 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 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 II · Moderate risk
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%
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
Chlorhexidine Gluconate 0.12% Oral Rinse
CGMP Deviations
Class II · Moderate risk
Doxycycline Hyclate USP
Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import Alert 66-66 for misbranding of active pharmaceutical ingredient.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Capsules USP
Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules.
Class II · Moderate risk
methylcobalamin 1mg/1mL
Lack of Assurance of Sterility
Class II · Moderate risk
Option 2
Defective Container: Carton is missing the tablet blister strip and tablet.
Class II · Moderate risk
Methocarbamol
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class II · Moderate risk
Caffeine Powder
Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The product is also misbranded as it fails to bear adequate directions for its intended use.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Class II · Moderate risk
Zenatane (isotretinoin)
Failed Dissolution Specifications: out of specification results observed for low dissolution.