CLASS III Drug recall · Reported 3 Oct 2012 · FDA Enforcement Report
Thallous Chloride Tl 201 Injection, Diagnostic Sterile recalled
Mallinckrodt is recalling Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) (, distributed in 11 states. The recall was initiated on 30 Jul 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1692-2012
- FDA event ID
- 62696
- Recalling firm
- Mallinckrodt, Hazelwood, MO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Jul 2012
- FDA classified
- 25 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Jul 2012 | Recall initiated by company | |
| 25 Sep 2012 | Classified by FDA | +57 days |
| 3 Oct 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
ArizonaCaliforniaConnecticutFloridaMissouriMississippiNorth CarolinaOklahomaPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Which lots are affected?
Lot 120-2686, exp. 8/2/12.
Where was it sold?
AZ, CT, MO, MS, PA, FL, WA, NC, CA, TX, OK
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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