D-0797-2026 Class II Ongoing
FDA drug recall D-0797-2026 was initiated by American Regent, Inc. on July 24, 2026 and is designated Class II. Reason for recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde The recall status is ongoing. Affected quantity: 169,200 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2026
- Initiation Date
- July 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169,200 vials
Product Description
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), 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
Distribution Pattern
Nationwide within the U.S
Code Information
Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.