BIMIX 30MG / 4MG INJECTABLE 10 ML — Class II drug recall D-1466-2012
Terminated recall by Franck's Lab Inc., d.b.a. Franck's Compounding Lab, reported 2012-08-22, distributed nationwide. Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed be
| Recall number | D-1466-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab, Ocala, FL, United States |
| Recall initiated | 2012-05-25 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, DO, GT, KY, PL, VE |
| Quantity | 448 units |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
Product
BIMIX 30MG / 4MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG / 5MG INJECTABLE 10 ML; BIMIX 9MG / 0.25MG INJECTABLE 10 ML, 5 ML; BIMIX 15MG / 1MG INJECTABLE 10 ML; BIMIX 18MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 18MG / 1MG INJECTABLE 5 ML; BIMIX 20MG / 0.75MG INJECTABLE 5 ML; BIMIX 26MG/1MG/ML INJECTABLE 10 ML; BIMIX 26MG/2MG/ML INJECTABLE 20 ML; BIMIX 30MG / 0.5MG INJECTABLE 10 ML, 20 ML,5 ML, 50 ML, 60 ML; BIMIX 30MG / 1.5MG INJECTABLE 5 ML; BIMIX 30MG/1MG INJECTABLE 1 ML, 10 ML, 10 MLS, 12 ML, 150 ML, 2 ML, 20 ML, 20 MLS, 3 ML, 30 ML, 40 ML, 5 ML, 5 MLS, 50 ML, 6 ML, 60 ML, 7 ML; BIMIX 9MG / 0.5MG/ML INJECTABLE 5 ML; BIMIX 15MG / 0.5MG INJECTABLE 10 ML, 5 ML; BIMIX 16.6MG / 0.55MG/ML INJECTABLE 10 ML, 4.5 ML; BIMIX 30MG / 2MG INJECTABLE 10 ML, 5 ML; BIMIX 30MG/3MG/ML INJECTABLE 10 ML, 5 ML; BIMIX 40MG/2MG INJECTABLE 10 ML, 3 ML, 6 ML; BIMIX 40MG/3MG INJECTABLE 3 ML; BIMIX, SDSM 9MG / 0.25MG INJECTABLE 10 ML; BIMIX, SDSM 9MG / 0.5MG INJECTABLE 10 ML; BIMIX, SDSM 18MG / 0.5MG INJECTABLE 10 ML, 10 MLS; BIMIX, SDSM 30MG / 1.5MG INJECTABLE 10 ML, 10 MLS, 5 ML, 5 MLS; BIMIX, SDSM 30MG / 1MG INJECTABLE 10 ML, 5 ML (58 DIFFERENT PRODUCTS)
Reason for recall
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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-1466-2012. 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.