FDA Drug recall D-1641-2012
VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of VITAMIN K (PHYTONADIONE) 10MG/ML INJECTABLE 1 ML 2 ML 4 ML by Franck S Lab D B A Franck S Compounding Lab, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1641-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-21 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Franck S Lab D B A Franck S Compounding Lab |
| Distribution | US |
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
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.
Identifiers
| code_info | Rx #'s: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806…Rx #'s: 0396112 0396112 0390633 0399923 0392295 0397930 0405691 0357875 0371933 0370806 0371933 0357875 0371933 0373258 0373258 0373258 0391775 0397909 0391540 0371152 0401946 0409588 0391886 0391886 0391886 0391886 0391867 0400517 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1641-2012%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.