The Recall Desk
SevereFDA (Drugs)·D-195-2013·Announced 2013-03-20

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.

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 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

Same manufacturer · A B Nutrition, Inc.

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Same hazard · unapproved drug

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