ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b)…

Is this the product you have?

• 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.

Lot codes and dates

• Lot #: 24418, Exp
• Date
  • 11/30/2026
  • 25131
  • Exp
• Date
  • 3/31/2027
  • 25349
  • Exp
• Date8/31/2027

Amount recalled

316,450 vials

This recall covers 14 products

The agency filed one notice per product. You are reading one of them; the other 13 are below.

• Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only…
• niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL…
• Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC…
• Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL…
• AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE…
• Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a)…
• ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR…
• Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in…
• Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1…
• Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose…
• Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC…
• Vial Label: Adequan i.m. polysulfated glycosaminoglycan, 500mg/5mL (100 mg/mL), 5mL…

1 more are in the archive.

Where it was sold

• Nationwide

Why it was recalled

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

This product could cause temporary or reversible health problems — stop using it.