Maximum Strength Acid Reducer recalled over manufacturing violations
- Recall date
- October 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Perrigo Company PLC recalls Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC…
- Recall number
- D-1017-2020
- FDA classification
- Class II
- Brand / firm
- Perrigo Company PLC
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51
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