Drug product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
D-0829-2018
Product summary
- Event
- Event 80006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,334 48-count bottles
- Official record key
drug-enforcement:D-0829-2018
Official wording
Reason: CGMP Deviations
Code information: Lot #: 3081542, Exp. 08/18 3081543, Exp. 08/18 3081544, Exp. 08/18 3082235, Exp. 08/18 3085903, Exp. 12/18 3088974, Exp. 06/19 3090445, Exp. 06/19
Distribution pattern: Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations