Class II · Moderate risk Terminated
Acetylcysteine 10% Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Acetylcysteine for Injection 6 g/30 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
- Recalling firm
- Akorn, Inc.
- NDC code
- 17478-660-30
- Origin
- IL, United States
- FDA recall number
- D-0916-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Acetylcysteine recalls
See all
Class II · Moderate risk Ongoing
ACETYLCYSTEINE OPTH 5% Solution
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk Ongoing
ACETYLCYSTEINE OPTH 10% Solution
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk Terminated
Acetylcysteine 2% Opth Soln
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Acetylcysteine 10% Opth Soln
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
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