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Class I: serious health riskTerminated

Gadget Island RHINO 7 Platinum 5000 Recall

RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distrib…

Gadget Island, Inc · Newark, CA

Risk level
Class I
Reported by FDA
Dec 13, 2017
Recall ID
D-0103-2018
Check your lot numberHow we source this data

Summary

Gadget Island recalled RHINO 7 Platinum 5000 starting Sep 15, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0103-2018 on Dec 13, 2017. Reason: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

Product description

RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0103-2018
Classification
Class I
Status
Terminated
Recall initiated
Sep 15, 2017
FDA report date
Dec 13, 2017
Quantity
925 1-capsule packets
Recall type
Voluntary: Firm initiated
Recalling firm
Gadget Island, Inc

Original FDA data

Every field from FDA enforcement report D-0103-2018, exactly as published.

Show all FDA fields
City
Newark
State
CA
Status
Terminated
Country
United States
Event ID
78151
Address
5889 Central Ave
Code information
All Lots
Postal code
94560-4465
Report date
Dec 13, 2017
Product type
Drugs
Recall number
D-0103-2018
Classification
Class I
Recalling firm
Gadget Island, Inc
Product quantity
925 1-capsule packets
Termination date
Dec 4, 2018
Reason for recall
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Voluntary / mandated
Voluntary: Firm initiated
Product description
RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
Distribution pattern
Nationwide in the USA
Recall initiation date
Sep 15, 2017
Initial firm notification
E-Mail
Center classification date
Dec 4, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0103-2018, published Dec 13, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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