FDA Drug recall D-1560-2012
LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML
- FDA Drug
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 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-1560-2012 |
| 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
LIDOCAINE HCL/EPINEPHRINE IN BSS - P.F., SULFITE-FREE 0.75%/0.025% INJECTABLE 24 ML 6 ML; LIDOCAINE HCL/EPINEPHRINE, P.F., SULFITE-FREE 2%/1:100,000 (0.001%) INJECTABLE 10 ML 40 ML; LIDOCAINE HCL/EPINEPHRINE. 2%/1:100,000 (0.001%) INJECTABLE 100 ML 1200 ML 300 ML 80 ML; LIDOCAINE/EPINEPHRINE 1%/0.00025% OPHTHALMIC 30 ML 60 ML 90 ML; LIDOCAINE/EPINEPHRINE, P.F. (FOR DILUTION WITH BSS+) 1.71%/0.057% OPHTHALMIC 14 ML 7 ML (8 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: 0397942 0397942 0395256 0395256 0387634 0397219 0400108 0387634 0370170…Rx #'s: 0397942 0397942 0395256 0395256 0387634 0397219 0400108 0387634 0370170 0370170 0370170 0389690 0389690 |
|---|
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-1560-2012%22
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