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Mozarc Medical US LLC

Mozarc Medical US LLC Recalls

All product recalls associated with Mozarc Medical US LLC.

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Recall Summary

Total Recalls

225

Past Year

Class I (Serious)

Most Recent

Oct 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 225 recalls

MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (2025)

A potential issue with the seal integrity of header bag packaging.

Low

FDAOct 17, 2025Nationwide• Mozarc Medical US LLC

Cyclophosphamide Injection (Sandoz) – temperature excursion (2025)

cGMP deviations: Temperature excursion during transportation.

Class IIModerate

FDASep 5, 2025Nationwide• Sandoz Inc

Burrito Bowl Blend (Good and Gather) – Undeclared Shrimp (2025)

Undeclared Allergen

Product may contain undeclared shrimp (crustacean shellfish).

Class IIModerate

12 3...12

Page 1 of 12Next

FDA

Sep 4, 2025

Nationwide

• ONE FROZEN, LLC

Ciprofloxacin Dexamethasone Otic Suspension (Sandoz) - Temperature Abuse (2025)

Temperature Abuse

Class IIModerate

FDAAug 13, 2025CA, IN• Sandoz Inc

Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Class IHigh

FDAJun 27, 2025Nationwide• Sandoz Inc

Penicillin G Potassium (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

Class IHigh

FDAJun 27, 2025Nationwide• Sandoz Inc

Infinia Nuclear Medicine System (GE Medical) – Detector Motion (2025)

Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.

Very High

FDAJun 20, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Varicam Nuclear Medicine System (GE Medical) – Detector Motion (2025)

Very High

FDAJun 20, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel

Frozen Shrimp (Chicken of the Sea) – Undeclared Sulfites (2025)

Undeclared Allergen

Frozen Raw Peeled & Deveined tail on, shrimp contains undeclared sulfites

Class IHigh

FDAMay 6, 2025CO, IN• TRI-UNION FROZEN PRODUCTS INC DBA CHICKEN OF THE SEA FROZEN FOOD