FDA-Drug2018-05-30Class II

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

Mylan Pharmaceuticals Inc.
Hazard

CGMP Deviations

Sold states
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Affected count
7,334 48-count bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0829-2018

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