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FDAFDA · Food and drugs·Recall number D-1024-2020

Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75

Published March 25, 2020 · Recall initiated: October 23, 2019

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 Deviation; Possible contamination with impurity N-nitrosodimethylamine.

What to do

Voluntary: Firm initiated · Press Release

Recall details

Manufacturer
Perrigo Company PLC
Distributor
Nationwide USA
Lot
Lots: 8EE1702, 8EE1703, 8EE1704, 8FE1724, 8GE1942, 8HE1396, 8HE1397, 8JE2156, 8KE2521, 8KE2523, 8LE2255, 8LE2665, 8LE2668, 9AE2541, 9AE2542, 9AE2543, 9BE2993, 9BE2994, 9BE2995, 9CE3735, 9CE3736, 9DE3108, 9DE3109, 9DE3110, 9EE2872, 9EE2880, 9FE3273, 9FE3276, 9GE2978, 9GE2979, 9HE3437, 9HE3438
Risk classification
Class II
Area (FDA)
drug
Country
United States