Why it was recalled
CGMP Deviation: Poor container closure of the bulk storage container
Product description
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
Lot numbers, UPCs & expiration codes
a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1238-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 5, 2015
- FDA report date
- Jul 22, 2015
- Quantity
- 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Geritrex Corp
Original FDA data
Every field from FDA enforcement report D-1238-2015, exactly as published.
Show all FDA fields
- City
- Mount Vernon
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 71441
- Address
- 144 Kingsbridge Road East
- Code information
- a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16
- Postal code
- 10550
- Report date
- Jul 22, 2015
- Product type
- Drugs
- Recall number
- D-1238-2015
- Classification
- Class III
- Recalling firm
- Geritrex Corp
- Product quantity
- 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
- Termination date
- Mar 13, 2017
- Reason for recall
- CGMP Deviation: Poor container closure of the bulk storage container
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 5, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 14, 2015