August 19, 2020DrugsFDA
Eosera, Inc. recalls Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX
Hazard: cGMP Deviations.
August 19, 2020DrugsFDA
Eosera, Inc. recalls Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5
Hazard: cGMP Deviations.
August 19, 2020DrugsFDA
Eosera, Inc. recalls Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South
Hazard: cGMP Deviations.
August 19, 2020DrugsFDA
Golden State Medical Supply Inc. recalls Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45),
Hazard: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
August 19, 2020DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls 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
Hazard: Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
August 19, 2020DrugsFDA
SCA Pharmaceuticals recalls Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd
Hazard: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
August 19, 2020DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutic
Hazard: Subpotent drug: Out of specification for assay at the 15-month test interval.
August 19, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake Cit
Hazard: Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
August 19, 2020DrugsFDA
West-Ward Columbus Inc recalls Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatont
Hazard: Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
August 12, 2020DrugsFDA
Spartan Chemical Co Inc recalls Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a
Hazard: Microbial contamination of non-sterile products: positive microbial contamination in product.
August 12, 2020DrugsFDA
Summitt Labs recalls KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREO
Hazard: Chemical Contamination; product contains elevated levels of lead
August 12, 2020DrugsFDA
Vilvet Pharmaceuticals Inc. recalls VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12
Hazard: cGMP deviations
August 12, 2020DrugsFDA
Vilvet Pharmaceuticals Inc. recalls VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and
Hazard: cGMP deviations
August 12, 2020DrugsFDA
Yusef Manufacturing Laboratories, LLC recalls Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7
Hazard: Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
August 12, 2020DrugsFDA
Mylan Institutional LLC recalls Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, R
Hazard: Presence of Particulate Matter
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro,
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle,
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, I
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. He
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ (30ML) bottles, Distributed by: B.C
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Berry, 1500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 9
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth,
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.
August 12, 2020DrugsFDA
MICHIGAN HERBAL REMEDIES recalls Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobe
Hazard: Chemical contamination: product contains elevated levels of undeclared lead.