FDA-Drug2019-07-31Class II
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Dercher Enterprises, Inc., DBA Gordon Laboratories
Hazard
Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.
Sold states
Nationwide in the USA
Affected count
277 boxes
Manufactured in
6801 Ludlow St, N/A, Upper Darby, PA, United States
Products
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1528-2019Don't want to check this manually?
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