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Records, not a safety rating.
Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.
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Recall Timeline
American Regent — 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.
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 11967. NDC 0517-3030-01 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.
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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 0517-0032-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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 Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
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 REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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 Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
American Regent — Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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