# FDA recall D-1692-2012

> **Mallinckrodt Inc** · Class III · drug recall initiated 2012-07-30.

## Product

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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** D-1692-2012
- **Recalling firm:** Mallinckrodt Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-07-30
- **Report date:** 2012-10-03
- **Termination date:** 2012-11-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hazelwood, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1692-2012

## Citation

> AI Analytics. FDA recall D-1692-2012. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1692-2012. Source: US FDA. Licensed CC0.

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