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Brilliant Blue G Urgent Product Immediate Recall
3/16/2012
The Food and Drug Administration (FDA) released this letter today that was written to physicians:
March 9, 2012
Dear Physician:
Our records indicate that your office received Brilliant Blue G compounded at Franck’s Lab. We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined. The following lots of Brilliant Blue G are suspected of fungal contamination:
Lot Number:
- 08232011@80
- 10132011@6
- 10112011@82
- 10192011@125
As a precautionary measure and to prevent any additional risk of eye infections in patients, we are recalling all Brilliant Blue G compounded by Franck’s Lab. You are requested to immediately quarantine and return to us any remaining Brilliant Blue G product you may still have. This includes ALL LOTS of Brilliant Blue G that you have received from Franck’s Pharmacy. Our accounting department will issue credit on receipt of product.
Please complete the recall response form and return the product to the address below with the postage provided. If you would like to report any adverse events, or if you would like to receive additional information regarding this product recall, please contact us Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209 and request the Pharmacist-in-Charge.
Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding
1
2Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770
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