Pallimed Solutions, Inc. located in Woburn, MA has decided to voluntarily recall all sterile compound products out of caution after a recent inspection by the FDA discovered visible filaments in 5 separate vials of the products Trimix, Bimix, Alprostadil, DMSO 50 Percent- Irrigation and Bacteriostatic Water for Injection.
The particulate substance found within the vials has not yet been identified, however no injury or illness has been reported. The vials were recalled due to precautionary measures considering the potential damage including obstructing blood vessels, causing allergic reactions or triggering unwanted tissue responses to the foreign substance.
The recalled products include all strengths and dosages of Pallimed’s 24 glass contained medications, and those recalled include a variety of uses includingerectile dysfunction , testosterone replacement, opthalmic preparations and vitamin injections. The medications were distributed to patients and physicians on Friday, March 22 in states such as: 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. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013, from Woburn, Massachusetts.
The medications being recalled are the following sterile compound products:
- Acetylcysteine Opthalmic Solution
- Al prostadil in NS Injections
- Atropine Injection
- Bacteriostatic Water for Injection BiMix Injection
- Buprenorphine HCl, Veterinary Injection
- Cidofovir OPH Solution
- Cyclosporine Opthalmic
- Diazepam Injectible
- Dexamethasone PF
- DMSO Aqueous Irrigation 50%
- Gentamicin Sulfate Irrigation
- HCG Chorionic Gonadotropin
- Hydroxyprogesterone Capr. (G.S.)
- Methylcobalamin- PF
- Mic with B6 and B12
- Nandrolone Decanoate Injectible
- Quadmix Injection
- Tacrolimus Opthalmic
- Testosterone Cypionate/Testosterone Enanthate Injection
- Testosterone Cypionate/Propionate Injection
- Testosterone Cypionate Injection
- Trimix Injection
- Vancomycin Opthalmic P.F.
- Verapamil Injection
Pallimed included all products dispensed since January 1, 2013 during the voluntary recall as an extra precautionary measure.
The company states, ”We deeply regret the impact this recall notice will have on our customers. Pallimed will continue to do everything possible to ensure patient safety and comply with all government standards and requirements.”
Affected users should discontinue product use and return to Pallimed. The company can be reached by telephone, Monday through Friday, 10 a.m. to 5 p.m, at (781) 937-3344 for any assistance in returns or complaints. Users who have received any of these recalled medications will be notified.
Any adverse effects related to the use of any of the recalled products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm.
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