Class III · Low risk
Derma-Smoothe/FS
Subpotent; 12 month stability timepoint
FDA Drug Recalls
530 recalls, newest first
Class I · High risk
Isovue -300
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class I · High risk
Isovue -370
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class II · Moderate risk
Nalbuphine HCl Injection
Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.
Class II · Moderate risk
Fluorouracil Topical Cream USP
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Class II · Moderate risk
Propranolol Hydrochloride Extended-release Capsules
Failed Dissolution Test Requirements
Class III · Low risk
EstroGel (estradiol gel)
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Class II · Moderate risk
Levothyroxine Tablets
Subpotent; 15 month stability (by mfr)
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Atorvastatin Calcium Tablets
Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.
Class II · Moderate risk
Vicks NyQuil Cold & Flu
Labeling Illegible: Portions of the product labeling in the area of the dosing directions, the warnings & other information sections is obscured.
Class II · Moderate risk
VIVITROL (naltrexone for extended-release injectable suspension)
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Class II · Moderate risk
traMADOL Hydrochloride Tablets
Adulterated Presence of Foreign Tablets: A customer complaint was received that a bottle of Tramadol HCl Tablets USP 50 mg contained some tablets of Metoprolol Tartrate Tablets USP, 50 mg.
Class II · Moderate risk
Pradaxa (dabigatran etexilate)
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Class II · Moderate risk
ABILIFY (aripiprazole)
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
Class II · Moderate risk
All Non-Sterile Products manufactured by Ameridose LLC
GMP deficiencies
Class II · Moderate risk
All Sterile Products manufactured by Ameridose LLC
Lack of assurance of sterility
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent; 15 month stability
Class II · Moderate risk
Epinephrine Injection USP
Presence of Particulates; may contain glass particles
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
Advair HFA
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
Class III · Low risk
ESTEE LAUDER DayWear Sheer Tint Release
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Class I · High risk
Ultimate Formula
Marketed Without An Approved NDA/ANDA: Products were found to contain undeclared sibutramine, the active ingredient in a previously approved FDA product indicated for weight loss but removed from the market for safety reasons, making these products unapproved new drugs.