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Unrated Drug recall · FDA · Published June 5, 2015

Geritrex Recalls Carb-O-Philic 40 Cream Due to CGMP Deviation

Geritrex Corp recalls specific lots of Carb-O-Philic 40% Cream due to poor container closure. Check your NDC and lot numbers for details.

🇺🇸 FDA recall #D-1238-2015DrugGeritrex ›
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Recalling firmGeritrex Corp144 Kingsbridge Road East · Mount Vernon, NY 10550
✎ GovInfoNow plain-language explainer

What happened, in plain English

Geritrex Corporation is recalling Carb-O-Philic 40 Cream, 40%, in both 3 oz. and 7 oz. tubes. The recall addresses a Current Good Manufacturing Practice (CGMP) deviation involving poor container closure of the bulk storage container. This issue affects specific lots with expiration dates of August 2016. Read more at govinfonow.com/recall/44205-geritrex-corp-recalls-carb-o-philic-40-cream-40-a.

Source Summary by GovInfoNow · govinfonow.com/recall/44205-geritrex-corp-recalls-carb-o-philic-40-cream-40-a · Updated October 12, 2026 · FDA enforcement record: FDA #D-1238-2015

Cite this page

“Geritrex Recalls Carb-O-Philic 40 Cream Due to CGMP Deviation.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44205-geritrex-corp-recalls-carb-o-philic-40-cream-40-a. Based on FDA recall #D-1238-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1238-2015%22&limit=1).

Why it’s dangerous

The hazard is described as a 'CGMP Deviation: Poor container closure of the bulk storage container.' The record does not explain what specific contamination, degradation, or safety risk results from this manufacturing issue.

Who’s affected

Individuals who have been prescribed Carb-O-Philic 40% Cream and possess tubes from the affected lots. The record does not specify which injuries or risks are associated with this specific CGMP deviation.

How to tell if you have this one

Look for Carb-O-Philic 40 Cream, 40%, Rx Only. Check for NDC 54162-640-03 (3 oz. tube) with Lot # 1502076 or NDC 54162-640-07 (7 oz. tube) with Lot # 1502077 or 1503030. All affected products have an expiration date of 08/16.

  • Brand
    Geritrex
  • Category
    Drug

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Jun 5, 201512. FDA classified it Class III: Jul 14, 201523. Published in FDA’s Enforcement Report: Jul 22, 201534. FDA terminated the recall: Mar 13, 2017420152017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Questions people ask

What is the specific health risk associated with this recall?

The record states there was a 'CGMP Deviation: Poor container closure' but does not describe the specific injury or health risk.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1238-2015 (June 5, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1238-2015 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA