Why it was recalled
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Product description
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide and France
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-1169-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 27, 2013
- FDA report date
- Mar 26, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fabscout Entertainment, Inc
Original FDA data
Every field from FDA enforcement report D-1169-2014, exactly as published.
Show all FDA fields
- City
- Ft Lauderdale
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65892
- Address
- 1458 NW 23rd Ave
- Code information
- All lots
- Postal code
- 33311-5147
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1169-2014
- Classification
- Class I
- Recalling firm
- Fabscout Entertainment, Inc
- Termination date
- Oct 2, 2019
- Reason for recall
- Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
- Distribution pattern
- Nationwide and France
- Recall initiation date
- Jun 27, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 20, 2014