The Recall Desk
ModerateFDA (Drugs)·D-0393-2016·Announced 2015-12-09

Geritrex Recalls Unapproved Polyethylene Glycol 3350 Powder Jars

Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars because the FDA determined they are unapproved new drugs and misbranded.

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, but the source text cites regulatory non-compliance (unapproved/misbranded) rather than specific health hazards or reported injuries, aligning with the 'Moderate' criteria for minor labeling or regulatory issues.

Plain-English summary

Geritrex Corporation is recalling Polyethylene Glycol 3350-GRX Powder 100% jars in 8.4 oz (250 g) and 16.9 oz (500 g) sizes. The recall involves specific lot numbers for both jar sizes, which were distributed nationwide.

The U.S. Food and Drug Administration (FDA) determined that these products are unapproved new drugs and misbranded because they were marketed without an Approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). This is an FDA Class II recall.

Consumers who have these products should stop using them and contact Geritrex Corporation for further instructions or a refund. The affected products are identified by specific NDCs and lot numbers listed in the official recall notice.

The recalled product

Product
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
Manufacturer
Geritrex Corp
Category
Drug — Over-the-Counter / Unapproved
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 (12)

  • Lot #: a) 1201092
  • 1403053
  • 1210028
  • 1007059
  • 1112105
  • 1305044
  • 1303079
  • 1406098
  • 1407061
  • 1505037
  • 1412004 1408081
  • b) 1112105 & 1007036

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Geritrex Corp 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 4 products in this recall →

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