PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

FDA recall notice · announced May 30, 2018 · Mylan Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

Reason for recall

CGMP Deviations

Notes

Distribution: Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Lot/code information: Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18
Quantity: 9,906 48-count bottles
Status: Terminated
Products in this recall event:
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22 (D-0829-2018)
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22 (D-0831-2018)
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22 (D-0830-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.