The Recall Desk
SevereFDA (Drugs)·D-194-2013·Announced 2013-03-20

A B Nutrition Recalls Unapproved Piracetam Dietary Supplement

A B Nutrition, Inc. is recalling 2,980 bottles of Piracetam 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the provided rubric, as it involves a product marketed without required regulatory approval.

Plain-English summary

A B Nutrition, Inc. is recalling 2,980 bottles of Piracetam Cognition Enhancing Agent Dietary Supplement, Pharmaceutical Grade 800 mg, 240 capsules per bottle. The product was manufactured by A B Nutrition, Inc. and distributed in retail stores in Texas and via internet sales nationwide. The specific lot number is 33250311 with an expiration date of 04/13.

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 U.S. Food and Drug Administration has classified this recall as Class II.

Consumers who purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for further instructions.

The recalled product

Product
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090
Manufacturer
A B Nutrition, Inc.
Category
Drug — Dietary Supplement
Hazard
Affected units
2,980

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 #33250311 Exp. 04/13

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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