Reported Aug 22, 2012 · Terminated
WATER BACT STERILE - (25X30ML)*** INJECTABLE 30 ML 750 MLS; WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML 10 MLS 100…
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?
- 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)
- Lot codes and dates
- Rx #'s:
270 of 270 codes
040884504003080404146040431404047340405632040657304067010407236040789404095570408043040822204037920404381040459704049370405274040560204058800405881040588904063070406538040655804075510410050041005104100540410335040380104046600405429040671404043830404424040442904044310408668040438104056410403996040417504043810404598040498504050570405274040552004056870406286040653804065730406905040728804080840408783040885504102290410380
- Rx #'s:
- Amount recalled
- 311 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. 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.
Want the full recall guide?
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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