Drug recall: PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed…
Class I FDA enforcement event 87981. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Miracle 8989 started this drug recall on 18 May 2021. The firm address in the FDA record is in Dallas, TX. FDA put the recall in Class I. FDA event 87981 has 3 product records. The first FDA enforcement report date is 30 Jun 2021. The record gives the status Terminated, with the termination date 12 Jul 2023.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
USA Nationwide
Recalling firm
Miracle 8989, Dallas, TX.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0633-2021 | PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006 | Unknown | Class I | Terminated | 30 Jun 2021 |
| D-0634-2021 | PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006 | Unknown | Class I | Terminated | 30 Jun 2021 |
| D-0635-2021 | maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028 | Unknown | Class I | Terminated | 30 Jun 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Drug events that started in 2021
- 299
- Share of these events in Class I
- 19%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-0633-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87981. https://recallregister.com/fda/i/87981/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
USA Nationwide
- What quantity of product is in FDA event 87981?
- The event has 3 product records. The first record gives this quantity:
Unknown
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2021 have the same class?
- 19% of the 299 drug events that started in 2021 are in Class I.