FDA Drug recall D-1643-2012
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS 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-1643-2012 |
| 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
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100 ML 100 MLS 1000 ML 110 ML 120 ML 130 ML 130 MLS 150 150 ML 150 MLS 160 ML 160 MLS 20 20 ML 200 ML 200 MLS 2000 ML 230 ML 240 ML 250 ML 250 MLS 30 ML 30 MLS 300 300 ML 300 MLS 40 ML 40 MLS 400 ML 400 MLS 50 50 ML 50 MLS 500 ML 500 MLS 60 60 ML 60 MLS 6800 ML 70 ML 7240 ML 7500 ML 80 ML 80 MLS 90 ML; WATER STERILE - USP (25X20ML)** INJECTABLE 1000 MLS 200 ML 200 MLS 300 MLS 400 MLS 500 ML 60 60 ML 600 20 600 ML; WATER STERILE - USP (25X50ML)** INJECTABLE 1000 ML 1150 ML 1250 MLS 1350 ML 150 MLS 2500 ML 300 ML 50 ML 500 ML 500 MLS 600 600 ML 600 MLS (72 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: 0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 040379…Rx #'s: 0408845 0400308 0404146 0404314 0404734 0405632 0406573 0406701 0407236 0407894 0409557 0408043 0408222 0403792 0404381 0404597 0404937 0405274 0405602 0405880 0405881 0405889 0406307 0406538 0406558 0407551 0410050 0410051 0410054 0410335 0403801 0404660 0405429 0406714 0404383 0404424 0404429 0404431 0408668 0404381 0405641 0403996 0404175 0404381 0404598 0404985 0405057 0405274 0405520 0405687 0406286 0406538 0406573 0406905 0407288 0408084 0408783 0408855 0410229 0410380 0404381 0409102 0404479 0405889 0404597 0404661 0404881 0405520 0405836 0405881 0406558 0405174 0404381 0406372 0407748 0405429 0403860 0403862 0404014 0404169 0404533 0404735 0405599 0405896 0406440 0406612 0406750 0407072 0407940 0408312 0408462 0408930 0409264 0410399 0404881 0405639 0405654 0405882 0405883 0406752 0407396 0404682 0408308 0404383 0404381 0404328 0406996 0409438 0404660 0404183 0404435 0405283 0405348 0406510 0406660 0407382 0407748 0407844 0409421 0409755 0404159 0405637 0405926 0406895 |
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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-1643-2012%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.