D-0829-2018 Class II Terminated
FDA drug recall D-0829-2018 was initiated by Mylan Pharmaceuticals Inc. on Apr 30, 2018 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Feb 14, 2019). Affected quantity: 7,334 48-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 30, 2018
- Initiation Date
- Apr 30, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0829-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026