A B Nutrition Recalls Unapproved Aniracetam Dietary Supplement
A B Nutrition, Inc. is recalling 912 bottles of Aniracetam dietary supplement because it is an unapproved new drug 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 agency classification is FDA Class II, which corresponds to a 'Severe' rating under the provided rubric, as it involves a reasonable probability of temporary or medically reversible adverse health consequences.
Plain-English summary
A B Nutrition, Inc. is recalling 912 bottles of ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement, Pharmaceutical Grade 750mg, 60 Capsules per bottle. The product was distributed in retail stores in Texas and via internet sales nationwide. The specific lot number is 32000311.
The recall was initiated because the product is an unapproved new drug that was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA classifies this recall as Class II.
Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090
- Manufacturer
- A B Nutrition, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 912
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)
- Lot # 32000311
Distribution
Part of a larger recall action
This product is one of 3 recalled by A B Nutrition, Inc. 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 →Related recalls
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