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Class I: serious health riskTerminated

www.vitaminbestbuy.com Hard Ten Days Capsule Recall

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federa…

www.vitaminbestbuy.com · Brewerton, NY

Risk level
Class I
Reported by FDA
Oct 3, 2012
Recall ID
D-1698-2012
Check your lot numberHow we source this data

Summary

www.vitaminbestbuy.com recalled Hard Ten Days Capsule starting Feb 23, 2012. The FDA classified it as Class I (serious health risk) and published enforcement report D-1698-2012 on Oct 3, 2012. Reason: Marketed Without an Approved ANDA/NDA: presence of sildenafil. Status: Terminated.

Why it was recalled

Marketed Without an Approved ANDA/NDA: presence of sildenafil

Product description

Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet

Lot numbers, UPCs & expiration codes

All lots.

Where it was sold

Nationwide

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-1698-2012
Classification
Class I
Status
Terminated
Recall initiated
Feb 23, 2012
FDA report date
Oct 3, 2012
Quantity
550 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
www.vitaminbestbuy.com

Original FDA data

Every field from FDA enforcement report D-1698-2012, exactly as published.

Show all FDA fields
City
Brewerton
State
NY
Status
Terminated
Country
United States
Event ID
61256
Address
6001 McKinley Rd.
Code information
All lots.
Postal code
13029
Report date
Oct 3, 2012
Product type
Drugs
Recall number
D-1698-2012
Classification
Class I
Recalling firm
www.vitaminbestbuy.com
Product quantity
550 boxes
Termination date
Nov 1, 2018
Reason for recall
Marketed Without an Approved ANDA/NDA: presence of sildenafil
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
Distribution pattern
Nationwide
Recall initiation date
Feb 23, 2012
Initial firm notification
E-Mail
Center classification date
Sep 26, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1698-2012, published Oct 3, 2012. 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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