FDAFDA · Food and drugs·Recall number D-1027-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
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: 8BE1032, 8BE1486, 8CE1638, 8DE1361, 8DE1612, 8FE1354, 8GE1737, 8HE1654, 8JE2237, 8KE2726, 8LE2369, 8ME2645, 9AE2777, 9CE3315, 9DE2720, 9EE2578, 9FE2956, 9GE2698, 9GE3202
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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