Carb-O-Philic 40 Cream (Geritrex) - CGMP Deviation (2015)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550
Brand
Geritrex Corp
Lot Codes / Batch Numbers
a) Lot # 1502076, Exp. 08/16 b) Lot # 1502077, 1503030, Exp. 08/16
Products Sold
a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16
Geritrex Corp is recalling Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx O due to CGMP Deviation: Poor container closure of the bulk storage container. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviation: Poor container closure of the bulk storage container
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026