FDAFDA · Food and drugs·Recall number D-1020-2020
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
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: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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