FDA-Drug2015-11-25Class III
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Akorn, Inc.
Hazard
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Sold states
Nationwide and Puerto Rico
Affected count
13,896 bottles
Manufactured in
1925 W. Field Court, Suite 300, N/A, Lake Forest, IL, United States
Products
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0295-2016Don't want to check this manually?
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