CGMP/Finished Pharmaceuticals/Adulterated
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CGMP/Finished Pharmaceuticals/AdulteratedeCTD Submission Standards for eCTD v4.0 and Regional M1
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0Charles 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 InvestigatAmneal Pharmaceuticals, LLC. Issues a Nationwide Voluntary Recall of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5mL, Due to the Potential for Some Bottles to be Super Potent Which May be Harmful
Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey (Amneal), is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level. Some bottles may have been overfilled which can resBiosimilars | Science and Research
Learn about FDA’s latest in biosimilar science and research.