FDA-Drug2020-02-19Class II
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Akorn Inc
Hazard
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
16,078 bottles
Manufactured in
1925 W Field Ct Ste 300, Lake Forest, IL, United States
Products
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2020Don't want to check this manually?
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