CLASS III Drug recall · Reported 26 Dec 2012 · FDA Enforcement Report
Choletec - Kit for the Preparation of Technetium Tc 99m recalled
Bracco Diagnostic is recalling Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per, distributed nationwide in the US. The recall was initiated on 14 Aug 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-095-2013
- FDA event ID
- 63535
- Recalling firm
- Bracco Diagnostic, Princeton, NJ
- Brand
- Choletec
- Manufacturer
- Bracco Diagnostics Inc
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Aug 2012
- FDA classified
- 19 Dec 2012
- Reported
- 26 Dec 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Aug 2012 | Recall initiated by company | |
| 19 Dec 2012 | Classified by FDA | +127 days |
| 26 Dec 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter; potential for charcoal particulates
Product as listed by the FDA
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543, by Hollister-Stier Laboratories LLC, Spokane Washington 99207, NDC 0270-0083-20.
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Presence of Particulate Matter; potential for charcoal particulates
Which lots are affected?
Lot #s: C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013.
Where was it sold?
Nationwide.
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.
More recalls from Bracco Diagnostic
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|---|---|---|---|---|---|
| Drug | CLASS III | E-z-cat Dry Barium Sulfate for Suspension (2% w/w after mixing) recalled | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS III | E-z- Gas II Effervescent Granules Antacid/Antiflatulent recalledE-z-gas | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS III | E-z-hd (barium sulfate) For Suspension (98% w/w) recalledE-z-hd | Bracco Diagnostic | Potency & Assay | Nationwide |
| Drug | CLASS I | Isovue -300 (Iopamidol) Injection 61% Prefilled recalled | Bracco Diagnostic | Particulate Matter | Nationwide |
| Drug | CLASS I | Isovue -370 (Iopamidol) Injection 76%, Prefilled mL recalled | Bracco Diagnostic | Particulate Matter | Nationwide |