B-Lipo Capsules Recalled for Containing Unapproved Controlled Substance Lorcaserin
Bethel Nutritional Consulting is recalling B-Lipo capsules because they contain Lorcaserin, a controlled substance, and were marketed without FDA approval.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of an unapproved controlled substance in a dietary supplement represents a significant regulatory and safety hazard.
Plain-English summary
Bethel Nutritional Consulting, Inc. is recalling B-Lipo, 30 Capsules, manufactured by KM DALI in Kunming, China. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The FDA determined that the capsules contain Lorcaserin, a controlled substance used for weight loss. The recall affects Lot #20213, which has an expiration date of 12/22/2016. The product was distributed nationwide.
Consumers who have purchased this product should stop using it and contact Bethel Nutritional Consulting, Inc. for further instructions or a refund.
The recalled product
- Product
- B-Lipo, 30 Capsules, Manufactured by KM DALI, Kunming, China for Bethel Nutritional Consulting, Inc.599 West 190th Street, Suite #1 NYC, NY 10040.
- Manufacturer
- Bethel Nutritional Consulting, Inc
- Category
- Drug — Dietary Supplement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 20213
- Exp 12/22/2016.
Distribution
Distributed nationwide across the United States.
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