Why it was recalled
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Product description
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Lot numbers, UPCs & expiration codes
Lot #: MFD:10.15.2017, Exp.10/14/2019.
Where it was sold
Product was distributed in California to online customers and retail stores.
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-0593-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 14, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- 32 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bella All Natural
Original FDA data
Every field from FDA enforcement report D-0593-2018, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 79327
- Address
- 304 E 11th St
- Code information
- Lot #: MFD:10.15.2017, Exp.10/14/2019.
- Postal code
- 90015-1715
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0593-2018
- Classification
- Class I
- Recalling firm
- Bella All Natural
- Product quantity
- 32 bottles
- Termination date
- Jan 28, 2019
- Reason for recall
- Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
- Distribution pattern
- Product was distributed in California to online customers and retail stores.
- Recall initiation date
- Feb 14, 2018
- Initial firm notification
- Press Release
- Center classification date
- Mar 13, 2018