FDA Drug Recalls

63 recalls · Class I, newest first

Class I · High risk Ongoing Dec 28, 2023

VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-029-68 D-0282-2024

Class I · High risk Ongoing Dec 28, 2023

VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-028-68 D-0281-2024

Class I · High risk Ongoing Dec 28, 2023

PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-150-82 D-0280-2024

Class I · High risk Ongoing Dec 28, 2023

PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-148-94 D-0279-2024

Class I · High risk Ongoing Dec 28, 2023

FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-072-82 D-0278-2024

Class I · High risk Ongoing Dec 28, 2023

FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark…

Reason Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

Denver Solutions, LLC DBA Leiters Health NDC 71449-072-41 D-0277-2024

Class I · High risk Ongoing Dec 26, 2023

Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed…

Reason Microbial Contamination of Non-Sterile Products

Haleon US Holdings LLC D-0317-2024

Class I · High risk Ongoing Dec 26, 2023

Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ…

Reason Microbial Contamination of Non-Sterile Products

Haleon US Holdings LLC D-0316-2024

Class I · High risk Ongoing Dec 21, 2023

Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake…

Reason Presence of particulate matter: glass

Pfizer NDC 61703-332-18 D-0261-2024

Class I · High risk Ongoing Dec 21, 2023

Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe…

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-4911-11 D-0235-2024

Class I · High risk Ongoing Dec 21, 2023

8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 50 mL…

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-6637-24 D-0234-2024

Class I · High risk Ongoing Dec 21, 2023

4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx…

Reason Presence of Particulate Matter; identified as glass

Pfizer Inc. NDC 0409-5534-24 D-0233-2024

Class I · High risk Ongoing Nov 29, 2023

Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7…

Reason Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Meta Herbal D-0206-2024

Class I · High risk Ongoing Nov 22, 2023