Reported Aug 22, 2012 · Terminated
INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN…
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?
- INDOCYANINE GREEN - KIT 15MG INJECTABLE 1 KIT, 100 KIT, 12 KIT, 20 KIT, 50 KIT, 6 KIT, 75 KIT, 8 KIT; INDOCYANINE GREEN - KIT 1MG INJECTABLE 1 KIT, 10 `KIT, 10 KIT, 100 KIT, 18 VIAL, 2 KIT (51 DIFFERENT PRODUCTS) 2 VIAL 20 KIT 22 KITS 25 KITS 3 KITS 3 VIALS 4 VIALS 5 KIT 50 KIT 50 KITS 6 KIT 60 KIT 8 KIT INDOCYANINE GREEN - KIT 25MG INJECTABLE 1 KIT 6 KIT INDOCYANINE GREEN - KIT 30MG INJECTABLE 10 KIT 14 KIT 25 KIT 5 KIT INDOCYANINE GREEN - KIT 5MG INJECTABLE 1 KIT 10 KIT 12 KIT 15 KIT 15 VIAL 2 KIT 20 KIT 25 KIT 3 KIT 4 KIT 5 KIT 6 KIT 8 KIT INDOCYANINE GREEN, LYOPHILIZED 15MG VIAL 1 VIAL INDOCYANINE GREEN, LYOPHILIZED 1MG VIAL 2 VIAL 5 VIAL INDOCYANINE GREEN, LYOPHILIZED 5MG VIAL 1 VIAL 2 KIT
- Lot codes and dates
- Rx #'s:
117 of 117 codes
039232103940250388514040191903506420394025038851403940250388514039073203907330390734039073503907360390737039073803803500368327037455603672410389528038767203876730388017038801903880220388506038851203885150392608039261503926160392619039262103961980396215039621603962290396231039943803994390399442039944504030090403010040301104030120403013040625904062600406262040634404079790407983040799404079950407997038952803803500391097
- Rx #'s:
- Amount recalled
- 134 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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