Oxiracetam & Choline , Oxiracetam 460mg Choline 110mg capsules a) 30 count bottle, b) 60 count bo...

FDA Drug Recall #D-236-2013 — Class II — March 11, 2013

Recall Summary

Recall Number D-236-2013
Classification Class II — Moderate risk
Date Initiated March 11, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Palmer Natural Products
Location Star, ID
Product Type Drugs
Quantity 472 - 30 count bottles; 203 - 60 count bottles; 458 - 90 count bottles

Product Description

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

Reason for Recall

Marketed Without an Approved NDA/ANDA: The products are unapproved drugs

Distribution Pattern

Florida, Idaho, California and Hong Kong. This product can be ordered on line.

Lot / Code Information

All lot codes

Other Recalls from Palmer Natural Products

Recall # Classification Product Date
D-232-2013 Class II Aniracetam and Choline, Aniracetam 460 mg, Chol... Mar 11, 2013
D-234-2013 Class II Brain Defogger, Piracetam 390mg Choline 104mg c... Mar 11, 2013
D-230-2013 Class II Aniracetam & Choline capsules, 430mg Aniracetam... Mar 11, 2013
D-231-2013 Class II NOOTROPA COGNITIVE ENHANCEMENT SUPPLEMENT, 400 ... Mar 11, 2013
D-235-2013 Class II BoostYourGrade.com, Piracetam 390mg Choline 104... Mar 11, 2013

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.