VITAMIN K — Class II drug recall D-1641-2012
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-1641-2012 |
|---|---|
| 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 | 2012-05-21 |
| Classified | 2012-08-10 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | BS, DO, GT, KY, PL, VE |
| Quantity | 38 units |
| Reason classes | microbial contamination, sterility |
| Pathogens | mold |
Product
VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML; VITAMIN K (PHYTONADIONE) 5MG/ML INJECTABLE 2 ML; VITAMIN A AQUEOUS EMULSION 50,000 U/ML INJECTABLE 20 ML 40 ML; VITAMIN B COMPLEX (B1,B2,B3,B5,B6) 100/5/100/100/100MG/ML INJECTABLE 120 ML 150 ML 180 ML 90 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML 20 ML 40 ML VITAMIN B COMPLEX (B1,B2,B3,B5,B6/ASCORBIC ACID/B12) 12.5/2/12.5/5/5/1MG/1MG/ML 60 ML VITAMIN B COMPLEX -PF (B1,B2,B3,B5,B6) 12.5/12.5/12.5/12.5/12.5MG/ML INJECTABLE 40 ML VITAMIN B COMPLEX PF (B1,B2,B3,B5,B6,B12) INJECTABLE 10 ML VITAMIN B-6/VITAMIN B-12 100MG/1000MCG/ML INJECTABLE 5 ML VITAMIN B-COMPLEX 100*** (30ML) INJECTABLE 30 ML VITAMIN COMPLEX (ASCOR,B1,B2,B3,B5,B6,B12,METH,INOS,CHL,LID) DR. HOLLOWAY INJECT 180 ML 240 ML 30 ML 60 ML VITAMIN D3 IN SESAME OIL 10,000 IU/ML INJECTABLE 60 ML (23 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. 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-1641-2012. 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.