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Class I: serious health riskTerminated

Natures Rx the silver bullet 10x Capsules Recall

the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extr…

Natures Rx · Claremont, CA

Risk level
Class I
Reported by FDA
Feb 13, 2019
Recall ID
D-0500-2019
Check your lot numberHow we source this data

Summary

Natures Rx recalled the silver bullet 10x Capsules starting Jan 25, 2019. The FDA classified it as Class I (serious health risk) and published enforcement report D-0500-2019 on Feb 13, 2019. Reason: Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil. Status: Terminated.

Why it was recalled

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

Product description

the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA

Lot numbers, UPCs & expiration codes

All lots within expiry

Where it was sold

eBay sales

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-0500-2019
Classification
Class I
Status
Terminated
Recall initiated
Jan 25, 2019
FDA report date
Feb 13, 2019
Quantity
211
Recall type
Voluntary: Firm initiated
Recalling firm
Natures Rx

Original FDA data

Every field from FDA enforcement report D-0500-2019, exactly as published.

Show all FDA fields
City
Claremont
State
CA
Status
Terminated
Country
United States
Event ID
81999
Address
310 N Indian Hill Blvd
Address (line 2)
Ste 600
Code information
All lots within expiry
Postal code
91711-4611
Report date
Feb 13, 2019
Product type
Drugs
Recall number
D-0500-2019
Classification
Class I
Recalling firm
Natures Rx
Product quantity
211
Termination date
Feb 6, 2023
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil
Voluntary / mandated
Voluntary: Firm initiated
Product description
the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens Extract, Horny Goat Weed, Ginger Root Extract, Icariin, Wolf Berry (fruit) Lactase, Tribulus Terrestris Extract, Piperine), 10 count mylar package, Nature's Rx, Claremont, CA
Distribution pattern
eBay sales
Recall initiation date
Jan 25, 2019
Initial firm notification
E-Mail
Center classification date
Feb 15, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0500-2019, published Feb 13, 2019. 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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