The Recall Desk

FDA (Drugs) recall action 61967

Mallinckrodt Inc. recalled 2 products on 2012-08-08

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-08-08
Critical
0
Units
85,430

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • LowFDA (Drugs)··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
    Distribution
    0 states
  • ModerateFDA (Drugs)··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
    Distribution
    0 states