FDAFDA · Food and drugs·Recall number D-1023-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
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: 8AE1884, 8BE1466, 8DE1318, 8CE1617, 8DE1319, 8EE1326, 8DE1611, 8DE1767, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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