🍔 Food 💊 Drugs 🏥 Medical Devices
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3 Class II

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

GlaxoSmithKline Consumer Healthcare Holdings LLC 20221202 Completed
Distributed: Nationwide within the United States
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VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-029-68. Class III

Reason: Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health 20231004 Terminated
Distributed: USA Nationwide
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VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-028-68. Class III

Reason: Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health 20231004 Terminated
Distributed: USA Nationwide
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Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70 Class III

Reason: Labeling: Not Elsewhere Classified

Denver Solutions, LLC DBA Leiters Health 20231004 Terminated
Distributed: USA Nationwide
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Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA Class II

Reason: Microbial contamination of Non-Sterile Products

Biomic Sciences, LLC dba ION Intelligence of Nature 20230929 Terminated
Distributed: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
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ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA Class II

Reason: Microbial contamination of Non-Sterile Products

Biomic Sciences, LLC dba ION Intelligence of Nature 20230929 Terminated
Distributed: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
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ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA Class I

Reason: Microbial contamination of Non-Sterile Products

Biomic Sciences, LLC dba ION Intelligence of Nature 20230929 Terminated
Distributed: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
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Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 Class III

Reason: Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

West-Ward Columbus Inc 20230922 Ongoing
Distributed: MS, OH
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