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Sevoflurane (Baxter Healthcare) – stability specification failure (2019)

Failed Stability Specifications

FDAJun 13, 2019Nationwide• Baxter Healthcare Corporation

Heparin Sodium (B. Braun Medical) – subpotent drug (2019)

Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.

Class IIModerate

FDAJun 13, 2019Nationwide• B. Braun Medical Inc

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Sevoflurane (Baxter Healthcare) – stability specification failure (2019)

Heparin Sodium (B. Braun Medical) – subpotent drug (2019)

Injectafer 720 MG (Infusion Options) – Sterility Concern (2019)

Topotecan 1.24 MG (Infusion Options) – Sterility Concern (2019)

Sodium Chloride 0.9% (Infusion Options) – Sterility Concern (2019)

Doxorubicin Syringe (Infusion Options) – Sterility Risk (2019)

Fluorouracil 560 MG (Infusion Options) – Sterility Concern (2019)

Infliximab 300 MG (Infusion Options) – Sterility Concern (2019)

Gazyva 100 MG (Infusion Options) – Sterility Concern (2019)

Docetaxel 60 MG (Infusion Options) – Sterility Concern (2019)

Ado-Trastuzumab (Infusion Options) – Sterility Concern (2019)

Abraxane 170 MG (Infusion Options) – Sterility Concern (2019)

Cytarabine (Infusion Options) – Sterility Concern (2019)

Perjeta 420 MG (Infusion Options) – Sterility Concern (2019)

Sodium Chloride (Infusion Options) – Sterility Concern (2019)

Paclitaxel Protein (Infusion Options) – Sterility Concern (2019)

Ifosfamide Infusion (Infusion Options) – Sterility Risk (2019)

Ramucirumab Infusion (Infusion Options) – Sterility Risk (2019)

Paclitaxel Albumin Infusion (Infusion Options) – Sterility Risk (2019)

Bortezomib Syringe (Infusion Options) – Sterility Risk (2019)