Drug Recall
Terminated
Historical recordClass 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.
by Golden State Medical Supply Inc.
- Reason
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Recall initiated
- July 24, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- Nationwide within the United States
View recall →
Drug Recall
Terminated
Historical recordClass 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.
by Taro Pharmaceuticals U.S.A., Inc.
- Reason
- Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
- Recall initiated
- July 20, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- Nationwide in the U.S.
View recall →
Drug Recall
Terminated
Historical recordClass 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
by SCA Pharmaceuticals
- Reason
- Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
- Recall initiated
- July 29, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- Product was distributed nationwide within the United States.
View recall →
Drug Recall
Terminated
Historical recordClass 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
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Subpotent drug: Out of specification for assay at the 15-month test interval.
- Recall initiated
- August 4, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- Nationwide USA
View recall →
Drug Recall
Terminated
Historical recordClass 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
by Teva Pharmaceuticals USA
- Reason
- Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
- Recall initiated
- July 14, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- Nationwide United States
View recall →
Drug Recall
Terminated
Historical recordClass 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
by West-Ward Columbus Inc
- Reason
- Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
- Recall initiated
- July 22, 2020
- Reported by FDA
- August 19, 2020
- Distribution
- OH and MS
View recall →
Drug Recall
Terminated
Historical recordClass 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.
by Spartan Chemical Co Inc
- Reason
- Microbial contamination of non-sterile products: positive microbial contamination in product.
- Recall initiated
- July 1, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide USA, Panama, St. Maarten
View recall →
Drug Recall
Terminated
Historical recordClass 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.
by Vilvet Pharmaceuticals Inc.
- Reason
- cGMP deviations
- Recall initiated
- July 24, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide within the US
View recall →
Drug Recall
Terminated
Historical recordClass 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.
by Vilvet Pharmaceuticals Inc.
- Reason
- cGMP deviations
- Recall initiated
- July 24, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide within the US
View recall →
Drug Recall
Terminated
Historical recordClass II
Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
by Yusef Manufacturing Laboratories, LLC
- Reason
- Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
- Recall initiated
- June 13, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- USA Nationwide
View recall →
Drug Recall
Terminated
Historical recordClass 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
by Mylan Institutional LLC
- Reason
- Presence of Particulate Matter
- Recall initiated
- July 7, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- USA Nationwide
View recall →
Drug Recall
Completed
Historical recordClass I
Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
Drug Recall
Completed
Historical recordClass 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
by MICHIGAN HERBAL REMEDIES
- Reason
- Chemical contamination: product contains elevated levels of undeclared lead.
- Recall initiated
- June 18, 2020
- Reported by FDA
- August 12, 2020
- Distribution
- Nationwide via internet sales,retailers and distributors in the USA
View recall →
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
Read the full medical disclaimer.