The Recall Desk
ModerateFDA (Drugs)·D-236-2013·Announced 2013-04-10

Palmer Natural Products Recalls Unapproved Oxiracetam and Choline Capsules

Palmer Natural Products is recalling Oxiracetam & Choline capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a risk of temporary or medically reversible adverse health consequences. The specific hazard is the marketing of unapproved drugs, which falls under moderate severity as no specific injuries or illnesses are reported in the source text.

Plain-English summary

Palmer Natural Products is voluntarily recalling Oxiracetam & Choline capsules in 30, 60, and 90-count bottles. The recall is being conducted because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning they are unapproved drugs.

The affected products were distributed in Florida, Idaho, California, and Hong Kong, and are also available for order online. The recall includes all lot codes for the 30-count, 60-count, and 90-count bottle sizes.

Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions or a refund.

The recalled product

Product
Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bottle, c) 90 count bottle, OTC, BoostYourGrade, LLC, Orlando, FL. 32826

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 lot codes

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 7 recalled by Palmer Natural Products 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 7 products in this recall →

Same manufacturer · Palmer Natural Products

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