FDAFDA · Food and drugs·Recall number D-0829-2018
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Published May 30, 2018 · Recall initiated: April 30, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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