CLASS III Drug recall · Reported 22 Jul 2015 · FDA Enforcement Report
Carb-O-Philic 40 Cream, 40%, a) tube recalled by Geritrex
Geritrex is recalling Carb-O-Philic 40 Cream, 40%, a) tube (, distributed nationwide in the US. The recall was initiated on 5 Jun 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1238-2015
- FDA event ID
- 71441
- Recalling firm
- Geritrex, Mount Vernon, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2015
- FDA classified
- 14 Jul 2015
- Reported
- 22 Jul 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 5 Jun 2015 | Recall initiated by company | |
| 14 Jul 2015 | Classified by FDA | +39 days |
| 22 Jul 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviation: Poor container closure of the bulk storage container
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviation: Poor container closure of the bulk storage container
Which lots are affected?
a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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