FDA-Drug2023-06-07Class II
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Akorn, Inc.
Hazard
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
N/A
Manufactured in
5605 Centerpoint Ct Ste A, N/A, Gurnee, IL, United States
Products
Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free, Rx Only, For Institutional Use Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. ALL NDCs
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0808-2023Don't want to check this manually?
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