Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
FDA Drug Recalls
401 recalls · Class II, newest first
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 II · Moderate risk
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Class II · Moderate risk
Necon 1/35-28
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Necon 10/11
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Zenchent (norethindrone and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Lutera (levonorgestrel and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Zovia (ethynodiol diacetate and ethinyl estradiol)
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).
Class II · Moderate risk
Perphenazine Tablets
Tablet Separation: Possibility of cracked or split coating on the tablets.
Class II · Moderate risk
QUETIAPINE Fumarate Tablets 25mg 100 Tablets
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk
Arranon (nelarabine)
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.
Class II · Moderate risk
All Non Sterile Products manufactured by NECC
GMP Deviations
Class II · Moderate risk
All Sterile Products manufactured by NECC
Lack of Assurance of Sterility
Class II · Moderate risk
Colloidal Silver
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.