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.
What this means for you
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
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.
Related recalls
Same manufacturer · Geritrex Corp
See all →- ModerateGeritrex Recalls Unapproved Carbo-O-Philic 40 Cream Tubes Nationwide
FDA (Drugs) · 2015-12-09
- ModerateGeritrex Recalls Unapproved Polyethylene Glycol 3350 Powder Jars
FDA (Drugs) · 2015-12-09
- SevereGeritrex Recalls Unapproved Hydrocortisone Suppositories Nationwide
FDA (Drugs) · 2015-12-09
- ModerateGeritrex Recalls Unapproved Carbo-O-Philic 40 Gel Topical Urea Product
FDA (Drugs) · 2015-12-09
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19