Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 Recalled by Geritrex Corp Due to Marketed without an Approved NDA/ANDA: FDA has determined...

Date: October 27, 2015
Company: Geritrex Corp
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Geritrex Corp directly.

Affected Products

Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550

Quantity: 3,796 jars (8.4 oz) 3,204, (16.9 oz) 3,350

Why Was This Recalled?

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Geritrex Corp

Geritrex Corp has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report