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Class II: temporary or reversible health riskTerminated

Namoo Enterprise PremierZen Black 5000 capsules Recall

PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by…

Namoo Enterprise LLC · Little Ferry, NJ

Risk level
Class II
Reported by FDA
May 5, 2021
Recall ID
D-0351-2021
Check your lot numberHow we source this data

Summary

Namoo Enterprise recalled PremierZen Black 5000 capsules starting Mar 25, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0351-2021 on May 5, 2021. Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. Status: Terminated.

Why it was recalled

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Product description

PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

Nationwide within the United States

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-0351-2021
Classification
Class II
Status
Terminated
Recall initiated
Mar 25, 2021
FDA report date
May 5, 2021
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Namoo Enterprise LLC

Original FDA data

Every field from FDA enforcement report D-0351-2021, exactly as published.

Show all FDA fields
City
Little Ferry
State
NJ
Status
Terminated
Country
United States
Event ID
87609
Address
215 Gates Rd
Address (line 2)
Unit S
Code information
All lots within expiry
Postal code
07643-1930
Report date
May 5, 2021
Product type
Drugs
Recall number
D-0351-2021
Classification
Class II
Recalling firm
Namoo Enterprise LLC
Termination date
Jul 16, 2021
Reason for recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Voluntary / mandated
Voluntary: Firm initiated
Product description
PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
Distribution pattern
Nationwide within the United States
Recall initiation date
Mar 25, 2021
Initial firm notification
Letter
Center classification date
Apr 26, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0351-2021, published May 5, 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.

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