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…
American Regent, Inc. · Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Status
- Ongoing
- City
- Shirley
- State
- NY
- Country
- United States
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 99503
- Recalling firm
- American Regent, Inc.
- Address 1
- 5 Ramsay Rd
- Postal code
- 11967-4701
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide within the U.S
- Recall number
- D-0797-2026
- Product quantity
- 169,200 vials
- Reason for recall
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Recall initiation date
- 20260724
- Center classification date
- 20260826
- Report date
- 20260826
- Code info
- Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
- 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.
- Harmonized identifiers (openFDA)
- Application number
- ANDA072489
- Brand name
- ACETYLCYSTEINE
- Generic name
- ACETYLCYSTEINE
- Manufacturer name
- American Regent, Inc.
- Product NDC
- 0517-7504, 0517-7604, 0517-7510, 0517-7610, 0517-7630
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- RESPIRATORY (INHALATION)
- Substance name
- ACETYLCYSTEINE
- RxCUI
- 307718, 307719
- SPL ID
- 2bcb9dd3-17f8-439e-a395-aa081c5cc4bf
- SPL set ID
- f56b4087-db48-4fd7-84ec-9c927962b805
- Package NDC
- 0517-7504-25, 0517-7604-25, 0517-7510-03, 0517-7610-03, 0517-7630-03, 0517-7604-01
- Is original packager
- true
- Upc
- 0305177510032, 0305177604250, 0305177504253, 0305177610039
- Nui
- N0000175429, N0000175961, N0000008867, N0000175960, N0000175776, N0000175547
- Pharm class epc
- Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Mucolytic [EPC]
- Pharm class pe
- Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE]
- Pharm class moa
- Reduction Activity [MoA]
- UNII
- WYQ7N0BPYC