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PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

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

Class IHigh

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Premier Value Tussin Cough DM (Seaway Pharma) – Microbial Contamination Risk (2023)

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

Class IIModerate

FDADec 28, 2023MI, PA• Seaway Pharma Inc.

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PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

Premier Value Tussin Cough DM (Seaway Pharma) – Microbial Contamination Risk (2023)

Quality Choice No Drip Nasal Pump Mist (Seaway Pharma) – Microbial Contamination Risk (2023)

PHENYLephrine HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

TruScan Body (TruAbutment) – scanning accuracy problems (2023)

Battle Motors LET2 (Battle Motors) – steering linkage fault (2023)

Impella Catheters (Abiomed) – myocardial wall risk (2023)

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GE Lullaby Incubator (GE Healthcare) – bedside panel issue (2023)

GE Neonatal Incubator (GE Healthcare) – bedside panel problem (2023)

GE Care Plus Hood (GE Healthcare) – bedside panel issue (2023)

Power Knee (Ossur) – battery failure risk (2023)

Hyundai Kona (Hyundai) – battery cable chafing (2023)

Volvo VNL (Volvo) – steering gear assembly fault (2023)

Mack Anthem (Mack) – steering gear misassembly (2023)

Benzonatate Capsules (Amerisource) – Superpotent Drug (2023)

Robitussin Honey CF Max Non-Drowsy (Haleon) – Microbial Contamination (2023)

Robitussin Honey CF Max Nighttime (Haleon) – Microbial Contamination (2023)

Senographe Pristina (GE Medical Systems) – x-ray signal issue (2023)

HRIS ACET Cup (Howmedica) – seal integrity failure (2023)