ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL) recall
American Regent, Inc. recalled ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL) on August 26, 2026 because of presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. It was sold nationwide.
Why it was recalled
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
What's recalled
ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Quantity: 316,450 vials
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- American Regent, Inc., Shirley, NY
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide within the U.S - Status
- Ongoing
- Recall number
- D-0796-2026
- Source
- U.S. Food and Drug Administration
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