Drug and pharmaceutical recalls

17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-08-12FDA-DrugSummitt LabsClass I
KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.
Chemical Contamination; product contains elevated levels of lead
2020-08-12FDA-DrugVilvet Pharmaceuticals Inc.Class II
VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.
cGMP deviations
2020-08-12FDA-DrugVilvet Pharmaceuticals Inc.Class II
VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.
cGMP deviations
2020-08-12FDA-DrugYusef Manufacturing Laboratories, LLCClass II
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
2020-08-12FDA-DrugMylan Institutional LLCClass I
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50
Presence of Particulate Matter
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99411 0
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ (30ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29086 6
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29082 8
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29085 9
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76539 1
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29081 1
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29088 0
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29087 3
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29083 5
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (30 ml) bottles,Distributed by: Recovery Releaf, West Palm Beach, FL
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
SP, hemp oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Pathway to Wellness
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99261 1
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99271 0
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
Chemical contamination: product contains elevated levels of undeclared lead.
2020-08-12FDA-DrugMICHIGAN HERBAL REMEDIESClass I
BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
Chemical contamination: product contains elevated levels of undeclared lead.

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