Why it was recalled
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Product description
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
Lot numbers, UPCs & expiration codes
Lot No: 9236999; Best use by: 12/16/2016
Where it was sold
NY
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-0101-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 12, 2016
- FDA report date
- Oct 26, 2016
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SOS Telecom Inc.
Original FDA data
Every field from FDA enforcement report D-0101-2017, exactly as published.
Show all FDA fields
- City
- Bayside
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 74144
- Address
- 20228 45th Ave
- Code information
- Lot No: 9236999; Best use by: 12/16/2016
- Postal code
- 11361-2540
- Report date
- Oct 26, 2016
- Product type
- Drugs
- Recall number
- D-0101-2017
- Classification
- Class I
- Recalling firm
- SOS Telecom Inc.
- Termination date
- Jul 6, 2018
- Reason for recall
- Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
- Distribution pattern
- NY
- Recall initiation date
- May 12, 2016
- Initial firm notification
- Press Release
- Center classification date
- Oct 14, 2016