Bestherbs Coffee LLC Issues Voluntary Nationwide Recall of New Kopi Jantan Tradisional Natural Herbs Coffee Due to the Presence of Undeclared Active Pharmaceutical Ingredients and Undeclared Milk
- Company Announcement Date:
- July 13, 2017
- FDA Publish Date:
- February 06, 2018
- Product Type:
- Food & Beverages
Food & Beverage Safety
- Reason for Announcement:
Recall Reason DescriptionUnapproved new drug, Undeclared Milk Allergen
- Company Name:
- Bestherbs Coffee LLC
- Brand Name:
Brand Name(s)New of Kopi Jantan Tradisional
- Product Description:
Product DescriptionNatural Herbs Coffee Dietary Supplement
Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional Natural Herbs Coffee, 13 grams to the consumer level. FDA laboratory analysis confirmed the presence of desmethyl carbodenafil. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED). New of Kopi Jantan Tradisional Natural Herbs Coffee also contains undeclared milk.
These undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. In addition, people who have an allergy or severe sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume this product.
New of Kopi Jantan Tradisional Natural Herbs Coffee is used as a male enhancement and is packaged in 13 gram red packs, UPC 557205060083 in a box and each box contains 25 packets. Bestherbs Coffee LLC distributed this product from July 2014 through June 2016. New of Kopi Jantan Tradisional Natural Herbs Coffee is consumed as an instant coffee. New Kopi Jantan Tradisional Natural Herbs Coffee was distributed nationwide to consumers via individuals or internet. No illness has been reported to date.
Bestherbs Coffee LLC is notifying its customers by phone. Consumers that have New of Kopi Jantan Tradisional Natural Herbs Coffee which is being recalled should stop using/discard/ and contact their doctor. Please return the product to Bestherbs Coffee LLC, 4250 Claremont Dr, Grand Priarie, TX 75052. Customers returning the product will be reimbursed by check for the returned goods and postage.
Consumers with questions regarding this recall can contact Bestherbs Natural Coffee at 817-903-2288 or Albertyee.firstname.lastname@example.org, Monday thru Friday 9am to 5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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