Class I · High risk Terminated
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial
Reason Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Marcaine
Reason Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Class I · High risk Terminated
1% LIDOCAINE HCl Injection
Reason Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, identified as iron oxide, were found embedded within the glass vial and floating in solution.
Class I · High risk Terminated
Cubicin
Reason Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.
Class I · High risk Terminated
Super ARTHGOLD 500mg
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Class I · High risk Terminated
Thinogenics
Reason Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.
Class I · High risk Terminated
Propofol Injectable Emulsion
Reason Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during a retain sample inspection where the glass vial contained visible embedded metallic particulate and free floating metallic particulates were also found in solution.
Class I · High risk Terminated
Mojo Risen
Reason Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Xzone Gold
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZONE GOLD because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Xzone 1200
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZone 1200because FDA laboratory analysis determined that they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Xzen 1200
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Xzen 1200 because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Xzen Platinum
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN PLATINUM because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Xzen Gold
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling XZEN GOLD because FDA laboratory analysis determined they contain undeclared amounts of sildenafil and tadalafil, active ingredients of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Black Ant
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
African Black Ant
Reason Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling AFRICAN BLACK ANT because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Class I · High risk Terminated
Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes
Reason Superpotent Drug: Product contains twice the stated amount of midazolam.
Class I · High risk Terminated
Esmeralda
Reason Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class I · High risk Terminated
Maxi Gold Weight Loss Pill
Reason Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class I · High risk Terminated
New Life Nutritional SUPER FAT BURNER
Reason Marketed without an approved NDA/ANDA - New Life Nutritional Center is recalling SUPER FAT BURNER, MAXI GOLD WEIGHT LOSS PILL and Esmeralda products marketed as Dietary Supplements due to the presence of undeclared and unapproved drugs.
Class I · High risk Terminated
Vpriv¿
Reason Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
Class I · High risk Terminated
REUMOFAN PLUS Tablets
Reason Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Class I · High risk Terminated
Venlafaxine HCl Extended-Release Capsules
Reason Presence of Foreign Tablets/Capsules: report of a foreign capsule with markings (TKN 250) and identified as a Tikosyn (dofetilide) capsule was found in a bottle of Effexor XR (venlafaxine HCl) 150 mg capsules that was packaged in the same packaging campaign as the recalled lot
Class I · High risk Terminated
Effexor XR
Reason Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.
Class I · High risk Terminated
Acetylcysteine Solution
Reason Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Class I · High risk Terminated
Citrulline
Reason Labeling: Label Mix-Up: FDA tested samples of API from Medisca, labeled as to contain L-Citrulline, and results revealed no L-Citrulline was present. Levels of N-acetyl-leucine were found instead.