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Class I: serious health riskTerminated

SOS Telecom Super Samurai-X Recall

Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box

SOS Telecom Inc. · Bayside, NY

Risk level
Class I
Reported by FDA
Oct 26, 2016
Recall ID
D-0104-2017
Check your lot numberHow we source this data

Summary

SOS Telecom recalled Super Samurai-X starting May 12, 2016. The FDA classified it as Class I (serious health risk) and published enforcement report D-0104-2017 on Oct 26, 2016. Reason: Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements. Status: Terminated.

Why it was recalled

Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements

Product description

Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.

Lot numbers, UPCs & expiration codes

Lot: 7920499; Best use by: 10/15/2016

Where it was sold

NY

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-0104-2017
Classification
Class I
Status
Terminated
Recall initiated
May 12, 2016
FDA report date
Oct 26, 2016
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
SOS Telecom Inc.

Original FDA data

Every field from FDA enforcement report D-0104-2017, exactly as published.

Show all FDA fields
City
Bayside
State
NY
Status
Terminated
Country
United States
Event ID
74144
Address
20228 45th Ave
Code information
Lot: 7920499; Best use by: 10/15/2016
Postal code
11361-2540
Report date
Oct 26, 2016
Product type
Drugs
Recall number
D-0104-2017
Classification
Class I
Recalling firm
SOS Telecom Inc.
Termination date
Jul 6, 2018
Reason for recall
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Voluntary / mandated
Voluntary: Firm initiated
Product description
Super Samurai-X , 1000 mg, 1 capsule per pack , 24 single packs per box.
Distribution pattern
NY
Recall initiation date
May 12, 2016
Initial firm notification
Press Release
Center classification date
Oct 14, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0104-2017, published Oct 26, 2016. 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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