Why it was recalled
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
Product description
SUPER HERBS 350 mg, 30 capsules per bottle.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
9 consignees - only 9 bottles distributed
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-0909-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 23, 2015
- FDA report date
- Jun 1, 2016
- Quantity
- 9 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Super Herbs
Original FDA data
Every field from FDA enforcement report D-0909-2016, exactly as published.
Show all FDA fields
- City
- Miami
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 73361
- Address
- 10740 Sw 222nd Dr
- Code information
- All lots
- Postal code
- 33170-6544
- Report date
- Jun 1, 2016
- Product type
- Drugs
- Recall number
- D-0909-2016
- Classification
- Class I
- Recalling firm
- Super Herbs
- Product quantity
- 9 bottles
- Termination date
- Oct 1, 2024
- Reason for recall
- Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SUPER HERBS 350 mg, 30 capsules per bottle.
- Distribution pattern
- 9 consignees - only 9 bottles distributed
- Recall initiation date
- Nov 23, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 26, 2016