Class I - Dangerous
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV 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.
Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV 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
D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV 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
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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
Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV 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
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
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