American Regent, Inc.: 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 I
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- Company / brand
- American Regent, Inc.
- Product
- 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.
- Reason / hazard
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the U.S
- Recall initiated
- 2026-07-24
- Code info
- Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
- Product quantity
- 316,450 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Shirley
- State
- NY
- Country
- United States
- Event id
- 99503
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