Geritrex Recalls Unapproved Carbo-O-Philic 40 Cream Tubes Nationwide
Geritrex Corporation is recalling Carbo-O-Philic 40 Cream tubes because the FDA determined the product is an unapproved new drug 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report specific injuries or illnesses, aligning with a moderate severity rating for regulatory non-compliance without confirmed harm.
Plain-English summary
Geritrex Corporation is recalling Carbo-O-Philic 40 Cream 40% (Urea) tubes, available in 3 oz and 7 oz sizes, distributed nationwide. The recall involves 9,948 tubes across four specific lot numbers. The FDA has determined that the 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 recall affects consumers who purchased the product. The source text does not specify reported illnesses or injuries associated with the use of this product. Consumers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
- Manufacturer
- Geritrex Corp
- Category
- Drug — Topical Cream
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 (3)
- Lot #: a)1502156
- 1507104 b)1503039
- 1507001
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 →Related recalls
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