Mallinckrodt Hospital Products Inc. Recalls

All product recalls associated with Mallinckrodt Hospital Products Inc..

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Recall Summary

Total Recalls

10

Past Year

0

Class I (Serious)

0

Most Recent

Feb 2024

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 1–10 of 10 recalls

Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

Terlivaz Injection (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

MD-Gastroview Contrast Solution (Mallinckrodt) – labeling issue (2015)

Labeling: incorrect or missing lot number and/or expiration date

Class IIModerate

FDAMay 15, 2015Nationwide• Mallinckrodt, Inc.

Thallous Chloride Injection (Mallinckrodt) – Mislabeled Containers (2012)

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

Class IIILow

FDAJul 30, 2012AZ, CA, CT +8 more• Mallinckrodt Inc

Hydrocodone Bitartrate and Acetaminophen (Mallinckrodt) – Expired Flavoring (2012)

CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.

Class IIModerate

FDAMay 25, 2012Nationwide• Mallinckrodt Inc.

Hydrocodone Acetaminophen Solution (Mallinckrodt) – Subpotent Dosage (2012)

Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.

Class IIILow

FDAMay 25, 2012Nationwide• Mallinckrodt Inc.

Mallinckrodt Inc: Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow compone...

The tubing metal begins to crack and thin. When this occurs it causes the tubing material to crack around the screws. This can cause the tubing to fall from the mounting plug.

FDAApr 14, 2008AL, AZ, AR +44 more• Mallinckrodt Inc

Mallinckrodt Inc: The OptiVantage DH Injection System is a contrast deliver...

Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.

FDAApr 7, 2008AL, AZ, AR +38 more• Mallinckrodt Inc

Mallinckrodt Inc: Angiomat Illumena Injector with Auxiliary Console, Mallin...

Synchronization problems: units that have both a main programmable console and an auxiliary programmable console, when simultaneously, injection parameters are programmed into the unit's main console and the unit's auxiliary consoles, mis-synchronization could occur resulting in a variance between the intended injection parameters (those programmed) and the actual parameters of the injection deliv

FDAAug 24, 2007AL, AZ, CA +27 more• Mallinckrodt Inc

Mallinckrodt Inc: OptiVantage DH Power Injection System.

The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinican, contrast would be injected at a higher or lower flow rate than desired.

FDANov 7, 2006PR• Mallinckrodt Inc

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Mallinckrodt Hospital Products Inc. Recalls

Recall Summary

Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

Terlivaz Injection (Mallinckrodt) – Shipping Temperature Issue (2024)

MD-Gastroview Contrast Solution (Mallinckrodt) – labeling issue (2015)

Thallous Chloride Injection (Mallinckrodt) – Mislabeled Containers (2012)

Hydrocodone Bitartrate and Acetaminophen (Mallinckrodt) – Expired Flavoring (2012)

Hydrocodone Acetaminophen Solution (Mallinckrodt) – Subpotent Dosage (2012)

Mallinckrodt Inc: Covidien/ Mallinckrodt CT9000, CT9000 ADV (J-Bow compone...

Mallinckrodt Inc: The OptiVantage DH Injection System is a contrast deliver...

Mallinckrodt Inc: Angiomat Illumena Injector with Auxiliary Console, Mallin...

Mallinckrodt Inc: OptiVantage DH Power Injection System.