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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71220

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 15, 2015
Product types
Drug
Classifications
Class II
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

1 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 1

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04

D-1132-2015
Recall number
D-1132-2015
Initiated
May 15, 2015
Classification
Class II
Status
Terminated
Recalling firm
Mallinckrodt, Inc.
Quantity
6600 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: incorrect or missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: B201B, Exp April 2015; B346D, Exp August 2015.

Distribution pattern

Costa Rica