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