A B Nutrition Recalls Unapproved Piracetam Powder Dietary Supplement
A B Nutrition, Inc. is recalling 509 bottles of Piracetam Powder marketed as a dietary supplement because it is an unapproved new drug.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 rubric, particularly given the product is an unapproved new drug.
Plain-English summary
A B Nutrition, Inc. is recalling 509 bottles of Piracetam Powder Cognition Enhancing Agent Dietary Supplement, 500 grams, Pharmaceutical Grade. The product was manufactured by A B Nutrition, Inc. and distributed in retail stores in Texas and via internet sales nationwide.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The FDA classifies the product as an unapproved new drug.
Consumers who purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
- Manufacturer
- A B Nutrition, Inc.
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 509
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 # 33280311 Exp. 03/13
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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FDA (Drugs) · 2013-03-20
- SevereA B Nutrition Recalls Unapproved Piracetam Dietary Supplement
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