Reported Aug 22, 2012 · Terminated
BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.25% / 1:200,000 INJECTABLE 900 ML; BUPIVACAINE HCL & EPINEPHRINE, P.F. 0.5% /…
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Franck's Lab Inc., d.b.a. Franck's Compounding Lab · 1210 SW 33rd Avenue · Ocala, FL · 34474-5138
Is this the product you have?
BUPIVACAINE HCL & EPINEPHRINEP.F. 0.25% / 1:200000 INJECTABLE 900 MLBUPIVACAINE HCL & EPINEPHRINEP.F. 0.5% / 1:200000 INJECTABLE 900 MLBUPIVACAINE HCL 0.25% INJECTABLE 120 ML180 ML240 ML250 ML300 ML500 ML60 MLBUPIVACAINE HCL 0.5% INJECTABLE1000 ML120 ML200 ML250 ML400 ML50 ML500 ML600 ML750 MLBUPIVACAINE HCLP.F. 0.25% INJECTABLE 1000 ML120 ML1200 ML150 ML1500 ML180 ML240 ML300 ML60 ML600 ML900 MLBUPIVACAINE HCLP.F. 0.5% INJECTABLE 10 ML120 ML1500 ML20 ML200 ML240 ML2500 ML300 ML360 ML600 ML960 MLBUPIVACAINE HCLP.F. 0.75% INJECTABLE 1200 ML150 ML240 ML30 ML600 ML7 ML (47 DIFFERENT PRODUCTS)
- Lot codes and dates
- Rx #'s:
04029640402963039808303985570398524040688303964970401829040744104084580408393039819603980840405518039707404016940401412039819604043250397888040744404085290408099040189704026140405996040261404053820398014039802204001970400116040019704018970405996039801404026140398014040175504017550404391040261604016880398026039974404026170398026040175503980260402616040085004046430408996040396004005090400960040375904046430405771
- Rx #'s:
- Amount recalled
- 79 units
This recall covers 198 products
The agency filed one notice per product. You are reading one of them; the other 197 are below.
185 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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