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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61967

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 25, 2012
Product types
Drug
Classifications
Class II and Class III
Statuses
Terminated
Recalling firm wording
Mallinckrodt Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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.

D-1430-2012
Recall number
D-1430-2012
Initiated
May 25, 2012
Classification
Class III
Status
Terminated
Recalling firm
Mallinckrodt Inc.
Quantity
41,100 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 0375T79384, Exp 05/13; 0375T81348, Exp 09/13; 0375U82277, Exp 01/14

Distribution pattern

Nationwide

drug · product 2 of 2

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.

D-1431-2012
Recall number
D-1431-2012
Initiated
May 25, 2012
Classification
Class II
Status
Terminated
Recalling firm
Mallinckrodt Inc.
Quantity
44,330 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: 0375P76192, Exp 07/12; 0375T80512, Exp 08/13; 0375T81209, Exp 09/13

Distribution pattern

Nationwide