The Recall Desk
SevereFDA (Drugs)·D-233-2013·Announced 2013-04-10

Unapproved Piracetam and Choline Capsules Recalled by FDA

Palmer Natural Products is recalling unapproved Piracetam and Choline capsules marketed without FDA approval.

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 status of the product as an unapproved drug.

Plain-English summary

Palmer Natural Products is recalling Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules. The product is available in 30-count and 100-count bottles and was marketed by BoostYourGrade, LLC in Orlando, Florida.

The FDA is recalling these products because they are unapproved drugs that were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall includes all lot codes.

The affected units were distributed in Florida, Idaho, California, and Hong Kong, and the product can also be ordered online. Consumers should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
Piracetam & Choline, 390mg Piracetam 104mg Choline Capsules, a) 30 count bottle, b) 100 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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