The Recall Desk

Manufacturer

Mallinckrodt, Inc.

5 recalls in our database name Mallinckrodt, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2015-06-17

Of the 5 recalls from Mallinckrodt, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Drugs)·D-1132-2015·2015-06-17

    Mallinckrodt Recalls MD Gastroview Due to Labeling Errors

    Mallinckrodt is recalling 6,600 bottles of MD Gastroview because some bottles have incorrect or missing lot numbers and expiration dates.

    Product
    MD GASTROVIEW — MD GASTROVIEW (DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1692-2012·2012-10-03

    Mallinckrodt Recalls Thallous Chloride Tl 201 Injection Due to Labeling Mismatch

    Mallinckrodt Inc. is recalling specific lots of Thallous Chloride Tl 201 Injection because outer container labels do not match the vial labels.

    Product
    Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration
    Category
    Drug
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-1431-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1430-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2081-2012·2012-08-01

    Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes

    Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.

    Product
    The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a s
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Mallinckrodt

Czech subsidiary of Mallinckrodt plc

Country
Czech Republic
Founded
1991
Parent company
Mallinckrodt Pharmaceuticals

Source: Wikidata (Q30269326), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.