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Clindamycin HCl Capsules (RemedyRepack) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 24, 2025PA• RemedyRepack Inc.

Connex Accessory Power Management Stand (Baxter) – Battery Fire Risk (2025)

Fire/Burn Risk

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

High

FDAMar 24, 2025Nationwide• Baxter Healthcare Corporation

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Clindamycin HCl Capsules (RemedyRepack) – CGMP Issues (2025)

Connex Accessory Power Management Stand (Baxter) – Battery Fire Risk (2025)

Intera 1.5T R11 (Philips) – Coil Seal Adhesive Failure (2025)

DuraShock Aneroid Gauge (Baxter) – undeclared rubber band (2025)

OEC 3D (GE Medical) – X-ray field distance issue (2025)

Connex Spot Monitor (Baxter) – undeclared rubber band (2025)

Blood Pressure Cuff Kit (Baxter) – undeclared rubber band (2025)

Connex Wall System (Baxter) – undeclared rubber band (2025)

ABL90 Series (Radiometer) – analyzer freeze risk (2025)

Green Series 777 Wall System (Baxter) – undeclared rubber band (2025)

CareStation 620 A1 (GE Healthcare) – ventilation ineffective (2025)

Spot Vital Signs 4400 (Baxter) – undeclared rubber band (2025)

CareStation 750 A1 (GE Healthcare) – ventilation ineffective (2025)

Phasor Drill (Phasor Health) – battery orientation risk (2025)

CareStation 650C A1 (GE Healthcare) – ventilation ineffective (2025)

Methocarbamol Injection (Somerset) – Sterility Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Haloperidol Decanoate Injection (Somerset) – Sterility Risk (2025)

Venlafaxine Tablets (Zydus) – Foreign Material Risk (2025)