Unapproved Piracetam and Choline Capsules Recalled by FDA
Palmer Natural Products is recalling unapproved Piracetam and Choline capsules marketed without FDA approval.
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 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 ,
- Manufacturer
- Palmer Natural Products
- Category
- Drug — Unapproved Drug
- Hazard
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
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.
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