Drug product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
D-0830-2018
Product summary
- Event
- Event 80006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,906 48-count bottles
- Official record key
drug-enforcement:D-0830-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18
Distribution pattern: Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations