PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Reported: May 30, 2018 Initiated: April 30, 2018 #D-0829-2018
Product Description
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Reason for Recall
CGMP Deviations
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 7,334 48-count bottles
- Distribution
- Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 7,334 48-count bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 30, 2018. Severity: Moderate. Recall number: D-0829-2018.
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