Class I - Dangerous
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Baptist Health Medical Towers Pharmacy and Infusion Services
Class I - Dangerous
Lack of Sterility Assurance
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Lack of Assurance of Sterility: Due to potential for leaking bags.
Class I - Dangerous
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010
Lucy's Weight Loss (dba. Waisted With Lucy)
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Stree Overlord, packaged in 10 small boxes / 1 capsule per box, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Black Ant King, packaged in BIG BOX (10 capsules / can / 12 cans per box / 120 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 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)
Class I - Dangerous
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Class I - Dangerous
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Plant Vigra, packaged in BIG BOX / (18 cans / 6 capsules per can / 108 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Man King, packaged in BIG BOX (8 small boxes / 5 capsules per box / 40 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Bull, packaged in CASE (10 packs / 3 capsules per can / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
Teva Pharmaceuticals USA
Class I - Dangerous
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Samurai-X, packaged in BIG BOX (24 individually wrapped capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.
Baxter Healthcare
Class I - Dangerous
Presence of Particulate Matter: identified as a cloth fiber.
Night Man, packaged in SMALL BOX (6 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Happy Passengers, packaged in BIG BOX (30 small boxes / 1 capsule per box / 30 capsules), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467
R Thomas Marketing
Class I - Dangerous
Marketed Without An Approved NDA/ANDA
Class I - Dangerous
Defective Delivery System; potential to have inaccurate dosage delivery