Lannett Ranitidine Syrup recalled over manufacturing violations
- Recall date
- October 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Lannett Company, Inc. recalls Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philade…
- Recall number
- D-0309-2020
- FDA classification
- Class II
- Brand / firm
- Lannett Company, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
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