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Class I: serious health riskTerminated

www.blankterrmall.com Hard Times For Men capsules Recall

Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one…

www.blankterrmall.com · Olean, NY

Risk level
Class I
Reported by FDA
Jan 31, 2018
Recall ID
D-0470-2018
Check your lot numberHow we source this data

Summary

www.blankterrmall.com recalled Hard Times For Men capsules starting Nov 19, 2017. The FDA classified it as Class I (serious health risk) and published enforcement report D-0470-2018 on Jan 31, 2018. Reason: Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil. Status: Terminated.

Why it was recalled

Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.

Product description

Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA

Lot numbers, UPCs & expiration codes

All lots within expiry.

Where it was sold

Product was distributed in the United States.

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-0470-2018
Classification
Class I
Status
Terminated
Recall initiated
Nov 19, 2017
FDA report date
Jan 31, 2018
Quantity
10 boxes
Recall type
Voluntary: Firm initiated
Recalling firm
www.blankterrmall.com

Original FDA data

Every field from FDA enforcement report D-0470-2018, exactly as published.

Show all FDA fields
City
Olean
State
NY
Status
Terminated
Country
United States
Event ID
78643
Address
2251 Constitution Ave
Code information
All lots within expiry.
Postal code
14760-1840
Report date
Jan 31, 2018
Product type
Drugs
Recall number
D-0470-2018
Classification
Class I
Recalling firm
www.blankterrmall.com
Product quantity
10 boxes
Termination date
Dec 11, 2018
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared active pharmaceutical ingredient (API) - Sildenafil.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Hard Times For Men capsules, packaged in a 23-count box of blister packs containing one capsule per pack, www.hardTimesPill.com, Distributed by: Natural Works LLC, USA
Distribution pattern
Product was distributed in the United States.
Recall initiation date
Nov 19, 2017
Initial firm notification
Press Release
Center classification date
Feb 20, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0470-2018, published Jan 31, 2018. 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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