  |
Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall
AUDIENCE: Ophthalmology, Urology, Primary Care, Pharmacy
ISSUE: FDA is notifying all physicians and medical care organizations who have ordered any compounded product sold as a sterile preparation by Franck's Compounding Pharmacy of Ocala, Florida, of the recall of all sterile products sold by Franck's since November 2011 due to the possibility of lack of sterility.
BACKGROUND: The recall is being carried out to the user physician. An active investigation of this matter by the CDC and FDA is ongoing at this time. In March 2012, FDA received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG), supplied by Franck's Pharmacy, during eye surgeries. Clinicians in several states reported the adverse events. In April 2012, FDA received reports of eye infections in patients who were given injections of Franck’s drug products containing triamcinolone during eye surgery.
RECOMMENDATIONS: FDA advises that any product received from Franck's since November 2011 not be used and customer/physicians follow the instructions provided by Franck’s. FDA also recommends that any adverse events suspected to be associated with use of the products be reported to FDA:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the press release, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
