Recall record at a glance
| Official record | D-1581-2012 |
|---|---|
| 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 | 1079 units |
| Location | Ocala, FL, United States |
Official product description
MITOMYCIN 1MG/ML SOLUTION 160 ML 40 ML 80 ML; MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC 0.5 ML 1 ML 1.5 ML 10 ML 12.5 ML 2 ML 2.5 ML 3 ML 30 ML 4 ML 5 ML 6 ML 7 ML; MITOMYCIN SOLUTION, STERILE 0.025% (250MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 6 ML MITOMYCIN SOLUTION, STERILE 0.03% (300MCG/ML) OPHTHALMIC 2 ML 3 ML 4 ML 5 ML; MITOMYCIN SOLUTION, STERILE 0.04% (400MCG/ML) OPHTHALMIC 1 ML 10 ML 12 ML 2 ML 20 ML 3 ML 3.6 ML 4 ML 5 ML 5.4 ML 6 ML 7.2 ML; MITOMYCIN SOLUTION, STERILE 0.05% (500MCG/ML) OPHTHALMIC 1.5 ML 10 ML 15 ML 2 ML 3 ML 5 ML; MITOMYCIN SOLUTION, STERILE/BUFFERED 0.5MG/ML INJECTABLE 80 ML; MITOMYCIN, LYOPHILIZED 1MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 3 VIAL 3 VIALS 4 VIAL 4 VIALS 5 VIAL 5 VIALS 50 VIAL 6 VIAL 6 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 20MG INJECTABLE 1 VIAL 10 VIAL 12 VIAL 15 VIAL 16 VIAL 17 VIALS 18 VIAL 2 VIAL 20 VIAL 24 VIAL 24 VIALS 3 VIAL 30 VIAL 4 VIAL 5 VIAL 6 VIAL 6 VIALS 7 VIAL 7 VIALS 8 VIAL 8 VIALS; MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 1 VIAL 1 VIALS 10 VIAL 10 VIALS 11 VIAL 12 VIAL 12 VIALS 13 VIAL 14 VIAL 15 `VIAL 15 VIAL 16 `VIAL 16 VIAL 17 `VIAL 18 VIAL 18 VIALS 2 `VIAL 2 VIAL 2 VIALS 20 VIAL 20 vials 23 `VIAL 23 VIAL 24 VIAL 3 VIAL 3 VIALS 30 VIAL 36 VIAL 4 VIAL 4 VIALS 40 VIAL 41 VIAL 5 VIAL 5 VIALS 50 VIAL 6 `VIAL 6 VIAL
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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