The Recall Desk
SevereFDA (Drugs)·D-0222-2017·Announced 2016-12-28

3rd Degree Capsules Recalled for Undeclared Sibutramine

Making It a Lifestyle is recalling 3rd Degree capsules because they contain undeclared sibutramine and were marketed without an approved NDA or ANDA.

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 severity score under the rubric for significant injury or property damage reports or high-risk conditions.

Plain-English summary

Making It a Lifestyle is recalling 3rd Degree capsules, 60-count bottles, because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall is due to the presence of undeclared sibutramine in the product.

The recall covers 1,000 bottles of the product, which were distributed nationwide. All lots are affected by this recall.

Consumers who have purchased 3rd Degree capsules should stop using the product and contact the manufacturer for further instructions.

The recalled product

Product
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
Affected units
1,000

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Making It a Lifestyle under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Making It a Lifestyle

See all →