FDAFDA · Food and drugs·Recall number D-1025-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
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:8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, 9GE3144
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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