- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Reason for Announcement:
Recall Reason DescriptionUnapproved new drug
- Company Name:
- Marmex Corp
- Brand Name:
Brand Name(s)Marmex Corp
- Product Description:
Product DescriptionMale Enhancement
Orange, CA, Marmex Corp is voluntarily recalling All lots of Blue Pearl All Natural Male Enhancement Supplement, 500mg to the consumer level. FDA analysis has found the products to contain sildenafil.
The presence of the undeclared active ingredients renders them unapproved drugs for which safety and efficacy have not been established.
Use of products with undeclared sildenafil may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and might be the most likely to get affected. To date, Marmex Corp has not received any reports of adverse events related to this recall.
Blue Pearl All Natural Male Enhancement Supplement capsules were marketed as a dietary supplement for male enhancement and is packaged in 1 unit of blister packs, with upc code - 847046009785. The affected lots are all lot numbers with an expiration date of 7/1/2018. It was distributed Nationwide between July 2016 and November 2017 to Retail and internet.
Consumers with questions regarding this recall can contact Marmex Corp by 657-333-2053 or firstname.lastname@example.org on weekdays between the hours of 9 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers who purchased the product should stop consuming it and return it to place of purchase. 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.
Marmex Corp. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. Marmex Corp promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our consumers.
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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