Mallinckrodt Recalls
6 recalls on record · August 1, 2012 to September 21, 2022 · Drugs, Medical Devices
Recalls by year
12
15
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 21, 2022Medical DevicesFDA
Mallinckrodt, LLC. recalls INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of th
Hazard: The INOmax DSIR Delivery System, manufactured by Mallinckrodt Pharmaceuticals, is not compatible with the upgraded version of the Leoni Plus ventilator, manufactured by Lowenstein Medical. The Leoni Plus ventilator was recently upgraded in 2021 by Lowenstein Medical, with new hardware and software, and the upgraded version cannot be appropriately connected with the INOmax DSIR as instructed in the INOmax DSIR Operators Manual (OM). The INOmax DSIR OM requires the use of a one-way valve with the Leoni Plus ventilator during High Frequency Oscillatory Ventilation mode and warns that use of the device without a one-way valve may result in high Nitric Oxide (NO) delivery.
June 17, 2015DrugsFDA
Mallinckrodt, Inc. recalls MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointest
Hazard: Labeling: incorrect or missing lot number and/or expiration date
October 3, 2012DrugsFDA
Mallinckrodt Inc recalls Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC
Hazard: Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
August 8, 2012DrugsFDA
Mallinckrodt Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mall
Hazard: CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
August 8, 2012DrugsFDA
Mallinckrodt Inc. recalls Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mall
Hazard: Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
August 1, 2012Medical DevicesFDA
Mallinckrodt Inc recalls The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shap
Hazard: A report was received from a Japanese distributor regarding a complaint from a hospital customer stating that ten packages of Handi Fil were not sealed.