Elevated risk U.S. Food and Drug Administration

Ram It, To The Moon Dietary Supplements for Male Sexual Enhancement recall: Product is tainted with sildenafil and tadalafil

Recall published 2+ years ago

Product is tainted with sildenafil and tadalafil

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Published
February 1, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Ram It, To The Moon
Product type
Dietary supplements
Distribution
Nationwide

Products covered by this recall

Dietary Supplements for Male Sexual Enhancement

What the company announced

Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of sildenafil in the Ram It & To The Moon products renders them unapproved drugs for which safety and efficacy have not been established, therefor subject to recall.

Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening. The products affected are men with diabetes, high blood pressure, high cholesterol, or heart disease. To date, Integrity Products. has not received any reports of adverse events related to this recall.

The product is marketed as dietary supplements for male sexual enhancement and is packaged in a blister card. 10 count boxes. Ram It & To The Moon were distributed to consumers nationwide via the Internet. We are notifying the public through this public announcement due to lack of ability to identify customers who may have received the product. Integrity Products. is notifying its customers that have the Ram It & To The Moon products to stop use and properly discard the product.

Consumers with questions regarding this recall can contact Integrity Products. at [email protected] , St Louis MO Monday – Friday 9am to 9pm Eastern Standard Time 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

Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Ram It, To The Moon — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Remedy named in the notice: Integrity Products. is notifying its customers that have the Ram It & To The Moon products to stop use and properly discard the product.

Company contact: Integrity Products — Consumers: Integrity Products, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Ram It, To The Moon dietary supplements recalled?

Product is tainted with sildenafil and tadalafil Risk Statements: Men with diabetes, high blood pressure, high cholesterol, or heart disease, may be on medications that if taken with these products could lower blood pressure to dangerous levels that could be life threatening.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Company recall announcements record, and contact the company if you are unsure.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

The notice says: Integrity Products. is notifying its customers that have the Ram It & To The Moon products to stop use and properly discard the product.

Where was the recalled product sold?

It was distributed nationwide.

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