Class II · Moderate risk
Duloxetine DR Capsules USP 60 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
FDA Drug Recalls
354 recalls, newest first
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 20 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules USP 30 mg
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II · Moderate risk
Progesterone Injection USP
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class II · Moderate risk
First Aid Beauty Ultra Repair Cream
CGMP Deviations; product intended for quarantine was inadvertently distributed
Class I · High risk
Adrenalin Chloride Solution
Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
CGMP Deviations
Class III · Low risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
LABELING: LABEL MIX-UP
Class III · Low risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops
LABELING: LABEL MIX-UP
Class I · High risk
FOUZEE SugarLin HERBAL FORMULA capsules
Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution USP
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Class III · Low risk
Diphenhydramine HCl 50 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Diphenhydramine HCl 25 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Acetaminophen Extra Strength 500 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Acetaminophen
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Acetaminophen Regular Strength
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class III · Low risk
Acetaminophen Extra Strength 500 mg
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Class I · High risk
Nhan Sam Tuyet Lien Truy Phong Hoan
Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I · High risk
FORCE FOREVER 400mg Tablets
Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.