ISSUE: 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.
BACKGROUND: 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.
RECOMMENDATION: 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. Consumers with questions regarding this recall can contact Marmex Corp by 657-333-2053 or email@example.com on weekdays between the hours of 9 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online: www.fda.gov/MedWatch/report
- Download form 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