D-1238-2015 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2015
- Initiation Date
- June 5, 2015
- Termination Date
- March 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
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
Reason for Recall
CGMP Deviation: Poor container closure of the bulk storage container
Distribution Pattern
Nationwide
Code Information
a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16