FindMyRecallSubscribe
Class I: serious health riskTerminated

Ummzy Krazy Night capsule Recall

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Man…

Ummzy, LLC · Palisades Park, NJ

Risk level
Class I
Reported by FDA
Jul 28, 2021
Recall ID
D-0662-2021
Check your lot numberHow we source this data

Summary

Ummzy recalled Krazy Night capsule starting Mar 30, 2021. The FDA classified it as Class I (serious health risk) and published enforcement report D-0662-2021 on Jul 28, 2021. Reason: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Product description

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860

Lot numbers, UPCs & expiration codes

All lots within expiry.

Where it was sold

USA Nationwide

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-0662-2021
Classification
Class I
Status
Terminated
Recall initiated
Mar 30, 2021
FDA report date
Jul 28, 2021
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Ummzy, LLC

Original FDA data

Every field from FDA enforcement report D-0662-2021, exactly as published.

Show all FDA fields
City
Palisades Park
State
NJ
Status
Terminated
Country
United States
Event ID
87624
Address
273 5th St
Address (line 2)
Unit A
Code information
All lots within expiry.
Postal code
07650-2088
Report date
Jul 28, 2021
Product type
Drugs
Recall number
D-0662-2021
Classification
Class I
Recalling firm
Ummzy, LLC
Termination date
Jun 9, 2022
Reason for recall
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
Distribution pattern
USA Nationwide
Recall initiation date
Mar 30, 2021
Initial firm notification
Press Release
Center classification date
Jul 16, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0662-2021, published Jul 28, 2021. 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.

How we source and update recall data · Report incorrect information

Other recent drug recalls