DMSO / BUPIVACAINE HCL 50%/0 — Class II drug recall D-1505-2012
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-1505-2012 |
|---|---|
| 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 | 107 units |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
Product
DMSO / BUPIVACAINE HCL 50%/0.5% INJECTABLE 100 ML, 50 ML; DMSO 100% INJECTABLE 100 ML; DMSO FORTIFIED IRRIGATION - W/O HEPARIN SOLUTION 350 ML; DMSO FORTIFIED IRRIGATION 50%/0.01%/44%/1% SOLUTION 1000 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO FORTIFIED IRRIGATION 50%/44%/1% SOLUTION 50 ML; DMSO FORTIFIED IRRIGATION W/LIDOCAINE 50%/0.01%/44%/1%/1% SOLUTION 250 ML; DMSO IRRIGATION - NACHO3 50% SOLUTION 100 ML, 300 ML, 400 ML, 500 ML, 600 ML; DMSO W/LIDOCAINE 50%/0.5% SOLUTION 100 ML, 1200 ML, 150 ML, 200 ML, 250 ML, 2500 ML, 30 ML, 300 ML, 400 ML, 50 ML, 500 ML, 600 ML (32 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-1505-2012. 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.