Drug 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
D-1238-2015
Product summary
- Firm
- Geritrex Corp
- Event
- Event 71441
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,488 tubes (1,008 3 oz. tubes and 480 7 oz. tubes)
- Official record key
drug-enforcement:D-1238-2015
Official wording
Reason: CGMP Deviation: Poor container closure of the bulk storage container
Code information: a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviation