Choletec — Class III drug recall D-095-2013
Terminated recall by Bracco Diagnostic Inc, reported 2012-12-26, distributed nationwide. Presence of Particulate Matter; potential for charcoal particulates
| Recall number | D-095-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostic Inc, Princeton, NJ, United States |
| Recall initiated | 2012-08-14 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2013-09-06 |
| Distributed | Nationwide (US) |
| Quantity | 196,280 vials |
| Reason classes | specification failure |
| NDC | 00270-0083, 00270-0083-20 |
| Lot numbers | C0672, C0689, C0723, C0799, C0852 |
| Expiration dates | 2012-09-30, 2012-10-31, 2012-12-31, 2013-02-28, 2013-05-31 |
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 for recall
Presence of Particulate Matter; potential for charcoal particulates
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-095-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.