D-0829-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- April 30, 2018
- Termination Date
- February 14, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,334 48-count bottles
Product Description
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Reason for Recall
CGMP Deviations
Distribution Pattern
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
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