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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62696

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

Open FDA event record

Event summary

Timeline bucket
July 30, 2012
Product types
Drug
Classifications
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

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

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, 9 mg sodium chloride and 0.9% (v/v) benzyl alcohol as a preservative, RX, Mallinckrodt Inc., St. Louis, MO 63134

D-1692-2012
Recall number
D-1692-2012
Initiated
July 30, 2012
Classification
Class III
Status
Terminated
Recalling firm
Mallinckrodt Inc
Quantity
12/2.8mCi-vials and 12/6.3mCi-vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

Code information

Lot 120-2686, exp. 8/2/12.

Distribution pattern

AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK