Ranitidine 150 mg tablet Original Supplier's Remedy Repackaged recalled over manufacturing violations
- Recall date
- December 11, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- RemedyRepack Inc. recalls Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
- Recall number
- D-0798-2020
- FDA classification
- Class II
- Brand / firm
- RemedyRepack Inc.
- Sold / distributed
- Product was distributed to two facilities in CA and NY.
Why it was recalled
CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
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