Defective Delivery System: Defective stem valve causes leakage of the propellant in the spray canister delivering no drug or an inadequate amount of the drug to be delivered.
Drugs Recalls
Prescription and over-the-counter medications
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Pacifico National, Inc.
Non-Sterility: Product tested positive for bacterial contamination.
Failed Impuities/Degradation Specifications
Weekend Prince, packaged in 24 individual cards / 2 capsules per card/ 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Mojo Risen, packaged in BIG BOX (24 individual cards / 2 capsules per card/ 48 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Pacifico National, Inc.
Non-Sterility: Product tested positive for bacterial contamination.
Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010
Lucy's Weight Loss (dba. Waisted With Lucy)
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Presence of Particulate Matter: identified as dried skin.
Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.
Pharmakon Pharmaceuticals
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Germany Niubian, packaged in BIG BOX (10 small boxes / 24 capsules per box / 240 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Bigger Longer More Time More Sperms, packaged in BIG BOX (6 small boxes / 6 capsules per small box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Super Hard, packaged in BIG BOX (20 small boxes / 6 capsules per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
African Black Ant, packaged in 8 small boxes / 6 capsules per box / 48 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Bull's Genital, packaged in CASE (10 Cans / 10 capsules per can / 100 capsules),Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Hard Ten Days, packaged in BIG BOX (6 small boxes / 6 capsules per box / 36 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Marketed Without An Approved NDA/ANDA
Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Centro Naturista
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.