Class II · Moderate risk Terminated
Acetylcysteine 10% Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Acetylcysteine 10% Ophth Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
What was recalled
Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
- Recalling firm
- Walter's Pharmacy
- NDC code
- 99999-9018-33
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0794-2016
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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