Drug product
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
D-0866-2017
Product summary
- Firm
- Gentell, Inc
- Event
- Event 77196
- Status
- Terminated
- Classification
- Class II
- Quantity
- 65 gallons
- Official record key
drug-enforcement:D-0866-2017
Official wording
Reason: GMP Deviations; product may not meet cGMP requirements
Code information: Product Code GEN-23240
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Manufacturing or process control
GMP Deviations