D-0829-2018 Class II Terminated

Recalled by Mylan Pharmaceuticals Inc. — Morgantown, WV

Recall Details

Product Type
Drugs
Report Date
May 30, 2018
Initiation Date
April 30, 2018
Termination Date
February 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