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Palimed Solutions, Inc. Sterile Compound Products: Recall - Visible Particulates Observed
AUDIENCE: Health Professional, Pharmacy, Patient
ISSUE: Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level, including all strengths, all dose forms, and all products within expiry date. Recent inspections conducted by the FDA and the Massachusetts Board of Registration in Pharmacy found visible particulates (filaments) observed in vials of several different sterile compounded products. See the Press Release for a listing of all products affected by this recall.
The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.
BACKGROUND: The products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations. All products are packaged in glass vials. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013.
Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.
RECOMMENDATION: Users or recipients should discontinue use and return the recalled products to Pallimed. All users who received any of the recalled products have been or will be notified by telephone, fax, electronic mail and/or regular mail of the recall. To return product, request assistance, or report complaints related to this recall, users should contact Pallimed at www.pallimed.com and by telephone at (781) 937-3344, Monday through Friday, between 10:00 a.m. and 5:00 p.m.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- 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 firm 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
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This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
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