Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Reported: March 14, 2018 Initiated: February 14, 2018 #D-0593-2018
Product Description
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Details
- Recalling Firm
- Bella All Natural
- Units Affected
- 32 bottles
- Distribution
- Product was distributed in California to online customers and retail stores.
- Location
- Los Angeles, CA
Frequently Asked Questions
What product was recalled? ▼
Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015. Recalled by Bella All Natural. Units affected: 32 bottles.
Why was this product 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 The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Critical. Recall number: D-0593-2018.
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