FDA Drug recall D-095-2013
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use,…
- FDA Drug
- Class III
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class III recall of Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use,… by Bracco Diagnostic, citing presence of Particulate Matter; potential for charcoal particulates.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-095-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-14 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bracco Diagnostic |
| Distribution | US |
Product
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.
Reason
Presence of Particulate Matter; potential for charcoal particulates
Identifiers
| ndc | 0270-0083-20 |
|---|---|
| code_info | 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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class III · 2014-10-15 · Bracco Diagnostic - E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc.,…
FDA Drug · Class III · 2014-08-20 · Bracco Diagnostic - Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-…
FDA Drug · Class I · 2013-02-13 · Bracco Diagnostic - Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Pri…
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-095-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.