The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1238-2015·Announced 2015-07-22

Geritrex Recalls Carb-O-Philic 40 Cream Due to Container Closure Deviation

Geritrex Corp is recalling Carb-O-Philic 40 Cream due to a CGMP deviation involving poor container closure of the bulk storage container.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Geritrex Corp is recalling Carb-O-Philic 40 Cream, 40%, in 3 oz. and 7 oz. tubes. The recall is due to a Current Good Manufacturing Practice (CGMP) deviation identified as poor container closure of the bulk storage container.

The affected products are Carb-O-Philic 40 Cream, 40%, manufactured by Geritrex Corporation in Mount Vernon, NY. The recall includes 1,488 tubes, consisting of 1,008 3 oz. tubes and 480 7 oz. tubes. The specific lots affected are Lot # 1502076 (Exp. 08/16) for the 3 oz. tubes, and Lot # 1502077 and 1503030 (Exp. 08/16) for the 7 oz. tubes. The products were distributed nationwide.

The FDA has classified this recall as Class III, which indicates that the product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the products should be returned to the pharmacy or point of purchase for disposal or credit, in accordance with standard recall procedures.

The recalled product

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
Manufacturer
Geritrex Corp
Category
Drug — Topical Cream
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 (4)

  • a) Lot # 1502076
  • Exp. 08/16 b) Lot # 1502077
  • 1503030
  • Exp. 08/16

Distribution

Distributed nationwide across the United States.

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