Table of contents
- Latest PremierZEN Lawsuit Updates
- June 15, 2021: FDA Updates Platinum 8000 Notice
- May 19, 2021: FDA Posts Miracle8989 Recall
- April 16, 2021: FDA Updates Extreme 3000 Notice
- April 6, 2021: FDA Posts Yolo Studio Recall
- April 1, 2021: FDA Posts NANA Collection Recall
- What Is Tadalafil?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- How Do I Report a Reaction to PremierZEN Pills?
- Which Lot Numbers Were Recalled for PremierZEN Pills?
- What Does MedlinePlus Say About Tadalafil and Nitrates?
- Did the FDA Warn About PremierZEN Before the Recalls?
- When Should I Call a Doctor After Taking PremierZEN Pills?
- Who Can I Contact Miracle8989 About the PremierZEN Recall?
PremierZEN male enhancement pills were recalled after FDA testing found hidden drugs in them. The pills contained undeclared tadalafil, and some also held sildenafil. These drugs may interact with nitrates and lower blood pressure to dangerous levels.
No lawsuit, class action or MDL has been filed over PremierZEN. The recalls and public notifications posted by the FDA are the only official actions.
The pills were sold online through Amazon and eBay as dietary supplements. If you have any, stop using them and talk to your doctor.
Latest PremierZEN Lawsuit Updates
June 15, 2021: FDA Updates Platinum 8000 Notice
On June 15, 2021, the FDA updated its public notification for PremierZen Platinum 8000 [1]. The update says miracle8989 had recalled the product, which it sold through eBay.
FDA laboratory analysis had confirmed sildenafil and tadalafil in the unit bought from eBay.com. These are the active ingredients in Viagra and Cialis.
May 19, 2021: FDA Posts Miracle8989 Recall
On May 19, 2021, the FDA posted the Miracle8989 recall notice [2]. Miracle8989 had announced it on May 18, 2021.
The notice lists all lots of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000. The cause is undeclared sildenafil and tadalafil.
April 16, 2021: FDA Updates Extreme 3000 Notice
On April 16, 2021, the FDA revised its notice on PremierZen Extreme 3000 [3]. The update says Hyobin LLC, doing business as Yolo Studio, and QMART had recalled the product.
The product was sold through Amazon fulfillment. FDA laboratory analysis confirmed that the unit bought from Amazon.com contains tadalafil, the active ingredient in Cialis.
April 6, 2021: FDA Posts Yolo Studio Recall
On April 6, 2021, the FDA posted the Yolo Studio recall notice [4]. Yolo Studio had first announced it on April 5, 2021.
Every lot of PremierZEN Extreme 3000, PremierZEN Black 5000 and Triple SupremeZEN Plus 3500 is covered, because of undeclared tadalafil. Consumers should stop using and destroy the pills.
April 1, 2021: FDA Posts NANA Collection Recall
On April 1, 2021, the FDA posted the NANA Collection LLC recall notice [5]. NANA Collection had announced it on March 30, 2021.
The recall takes in all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500. The cause is undeclared tadalafil, and the Gold 3500 also contains sildenafil.
What Is Tadalafil?
According to MedlinePlus, tadalafil (Cialis) treats erectile dysfunction. It also treats the symptoms of benign prostatic hyperplasia. It is in a class of medications called PDE inhibitors, short for phosphodiesterase [6].
The FDA found tadalafil in PremierZEN pills that did not name it on the label. That matters most to anyone who also takes nitrates.
Who May Be Affected?
People who bought PremierZEN pills through Amazon or eBay may be affected. The risk is highest for those with diabetes, high blood pressure or heart disease who take nitrates such as nitroglycerin. That is the interaction the FDA describes.
Whether you have a claim depends on your own facts, and only an individual legal review by a lawyer can say.
Reported Injuries or Damages
No court has heard allegations of harm from PremierZEN pills. What is known about the risk comes from the FDA and from the sellers’ own recall notices.
Each recall notice says the company has not received any reports of adverse events related to the recall. That includes Yolo Studio, NANA Collection LLC and the Miracle8989 seller, Annie Cho.
The FDA warns that the hidden drugs may interact with nitrates found in some prescription drugs, such as nitroglycerin. This may cause blood pressure to fall to dangerous levels. These are regulator findings, not court findings.
The notices tell consumers to contact their physicians or healthcare provider. This applies to any problems that may be related to taking or using the product.
Recall and Regulatory Background
Three sellers recalled PremierZEN products: Yolo Studio, NANA Collection and the eBay seller Miracle8989. A recall does not prove liability.
Evidence to Preserve
Keep these items if you bought or took PremierZEN pills:
- The pill packaging and any remaining pills, including lot numbers and UPC codes.
- Amazon or eBay order records and receipts that show what you bought and when.
- Photographs of the product, its label and its packaging.
- A note of any symptoms and the dates they began.
- Medical records and a list of the medicines you take, including any nitrates.
- Any FDA report you file and any messages with the seller.
Filing Deadlines
State law sets the time limit for filing. It changes with where you live and with when the illness or injury and its diagnosis happened.
A missed cutoff can end a claim, even one with strong facts. Speak with a lawyer promptly if you think PremierZEN pills harmed you.
Frequently Asked Questions
How Do I Report a Reaction to PremierZEN Pills?
You can report a reaction to PremierZEN pills to the FDA’s adverse event reporting program. You can also call the seller. Yolo Studio lists the number (201) 233-3521, and NANA Collection LLC lists 201-773-8545.
Which Lot Numbers Were Recalled for PremierZEN Pills?
Every lot number of PremierZEN pills was recalled in the three notices. The NANA Collection notice names GATCO 01671 and GATCO 1805, with expiration date 12/30/2024. Miracle8989 lists UPC 728175421832 for Gold 7000 and Platinum 8000, and 718122040728 for MaxxZEN Platinum 12000.
What Does MedlinePlus Say About Tadalafil and Nitrates?
MedlinePlus says about tadalafil and nitrates that you should tell your doctor if you take nitrates, such as isosorbide dinitrate, isosorbide mononitrate or nitroglycerin. It adds that your doctor will probably tell you not to take tadalafil if you are taking nitrates.
Did the FDA Warn About PremierZEN Before the Recalls?
Yes, the FDA warned about PremierZEN before the recalls. On December 17, 2020, it advised consumers not to purchase or use PremierZen Extreme 3000 and PremierZen Platinum 8000. Both were sold for sexual enhancement on various websites.
When Should I Call a Doctor After Taking PremierZEN Pills?
You should call a doctor after taking PremierZEN pills if you have chest pain, dizziness or an erection that lasts longer than 4 hours. That is MedlinePlus guidance for tadalafil, the drug the FDA found in the pills.
Who Can I Contact Miracle8989 About the PremierZEN Recall?
You can contact Miracle8989 about the PremierZEN recall by calling 972-799-0080 or emailing powerfulll4u@gmail.com. The eBay seller, Annie Cho, lists hours of Mon-Fri 09:00-17:00 CST for consumer questions.