Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2020-08-19FDA-DrugGolden State Medical Supply Inc.Class III
Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
2020-08-19FDA-DrugTaro Pharmaceuticals U.S.A., Inc.Class III
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
2020-08-19FDA-DrugSCA PharmaceuticalsClass II
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
2020-08-19FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Subpotent drug: Out of specification for assay at the 15-month test interval.
2020-08-19FDA-DrugTeva Pharmaceuticals USAClass II
Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
2020-08-19FDA-DrugWest-Ward Columbus IncClass III
Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
2020-08-12FDA-DrugSpartan Chemical Co IncClass I
Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.
Microbial contamination of non-sterile products: positive microbial contamination in product.
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.

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