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Class I: serious health riskTerminated

D.B.P. Distribution Titanium 4000 Recall

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distrib…

D.B.P. Distribution · Chatsworth, CA

Risk level
Class I
Reported by FDA
May 22, 2019
Recall ID
D-1292-2019
Check your lot numberHow we source this data

Summary

D.B.P. Distribution recalled Titanium 4000 starting Apr 23, 2019. The FDA classified it as Class I (serious health risk) and published enforcement report D-1292-2019 on May 22, 2019. Reason: Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil. Status: Terminated.

Why it was recalled

Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.

Product description

Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020

Lot numbers, UPCs & expiration codes

Expiration 12/29/2020

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-1292-2019
Classification
Class I
Status
Terminated
Recall initiated
Apr 23, 2019
FDA report date
May 22, 2019
Quantity
unknown
Recall type
Voluntary: Firm initiated
Recalling firm
D.B.P. Distribution

Original FDA data

Every field from FDA enforcement report D-1292-2019, exactly as published.

Show all FDA fields
City
Chatsworth
State
CA
Status
Terminated
Country
United States
Event ID
82758
Address
23550 Ehlers Dr
Code information
Expiration 12/29/2020
Postal code
91311-6310
Report date
May 22, 2019
Product type
Drugs
Recall number
D-1292-2019
Classification
Class I
Recalling firm
D.B.P. Distribution
Product quantity
unknown
Termination date
Mar 7, 2023
Reason for recall
Marketed without an approved NDA/ANDA: undeclared sildenafil and tadalafil.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Titanium 4000, capsule, 4000 mg, 1 count blister card, 30 blister display boxt, distributed by Titanium 4000 UPC 86077000020
Distribution pattern
Nationwide.
Recall initiation date
Apr 23, 2019
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
May 22, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1292-2019, published May 22, 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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