Class II · Moderate risk Ongoing
N-Acetyl-L-Cysteine for Injection
Reason Lack of Assurance of Sterility
Acetylcyst 10% OPHT SOL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
What was recalled
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
- Recalling firm
- Medicap Pharmacy
- NDC code
- 99999-9996-94
- Origin
- ID, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1447-2016
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 Acetyl recalls
See all
Class II · Moderate risk Terminated
Acetylcysteine 10% Ophthalmic Solution
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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
Miocol-E
Reason cGMP deviations: Temperature abuse
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