Drug recall D-0796-2026
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 for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Lots and codes
Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
Recall details
- Recalling firm
- American Regent, Inc., Shirley, NY
- Quantity
- 316,450 vials
- Distribution
- Nationwide within the U.S
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 24, 2026
Related products
- Acetylcysteine – drug information
- NDC 0517-7610 Acetylcysteine · Acetylcysteine 200 mg/mL · American Regent, Inc.
- NDC 0517-7510 Acetylcysteine · Acetylcysteine 100 mg/mL · American Regent, Inc.
- NDC 0517-7604 Acetylcysteine · Acetylcysteine 200 mg/mL · American Regent, Inc.
- NDC 0517-7504 Acetylcysteine · Acetylcysteine 100 mg/mL · American Regent, Inc.