Recall record at a glance
| Official record | D-1643-2012 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Franck's Lab Inc., d.b.a. Franck's Compounding Lab |
| Report date | Aug 22, 2012 |
| Recall initiation date | May 21, 2012 |
| Quantity | 311 units |
| Location | Ocala, FL, United States |
Official product description
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)
Why the product 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.
Distribution information
Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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