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TradepilotUSA Recalls

shirley, New York — TradePilot Recalls

Official product recall notices and clearly labeled enforcement reference records.

Reference notice · drug

American Regent, Inc. — Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY

Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

Shirley, NY, US · Updated 9/16/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — 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, AM

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

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 INJECTION (NDC 0517-7504-25), Rx Only, AM

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25),

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

Reference notice · drug

American Regent, Inc. — Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10)

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

Shirley, NY, US · Updated 8/26/2026, 12:00:00 AM UTC

Source: FDA — drug enforcement reference

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