Unapproved New Drugs/Misbranded
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SLR Food Distribution of Hicksville, NY is recalling Wise Wife brand Cinnamon, because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be the onlyFDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumorsCertification Process for Designated Medical Gases
This guidance explains how FDA administers the certification process and describes the annual reporting requirements for designated medical gases (DMGs).Charles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/13/2020
Short Title (70 char) Charles H. Harper, M.D. Norfolk, NE. EIR issued 11/13/2020
FEI Number 3015685119
Firm Name Charles H. Harper, M.D.
Record Type EIR
State NE
Establishment Type Clinical InvestigatQ&A on CGMP Requirements
Pharmaceutical Quality/Manufacturing Standards (CGMP)FDA Listing of Authorized Generics
FDA Listing of Authorized Generics
