Pallimed Pharmacy Issues Voluntary Recall of Limited Products, Suspends Certain Compounding Activities
Precautionary measure taken to ensure patient safety even though no recalled products known to be contaminated and
no report of patient effects cited
**We will continuously update our website as more information is available**
Since 2006, the Pallimed team has proudly dedicated itself to providing the highest quality products and the highest possible level of safety and service to the patients, doctor, and hospitals we serve. Pallimed his always placed patient safety as its highest priority.
To ensure patient safety, Pallimed today (Monday, March 25, 2013) issued a voluntery recall of certain sterile compound products dispensed since January 1, 2013. The company took th is aggressive precautionary recall measure on the basis of information observed during the course of an inspection conducted by the U.S. Food and Drug Administration and the Massachusettss Board of Regestration in Pharmacy.
Please note that we have no indication that any product made by Pallimed is unsafe or that any recalled product has been contaminated. To date, no injuries or illnesses have been reported. Pallimed is undertaking this aggressive precautionary recall measure in an abundance of caution to ensure patient safety.
This recall is limited only to sterile compounded products dispensed on or after January 1, 2013. A complete list of all products subject to this recall goes as follows:
Alprostadil in NS Injection Gentamicin Sulfate Irrigation Testosterone Cypionate/Propionate Injection
Atropine Injection Methylcobalmin, PF Testosterone Cypionate Injection
Bacteriostatic H20 HCG Trimix Injection
Bimix Injection Mic with B6 & B12 Vancomycin Ophthalmic, PF
Cyclosporine Ophthalmic Quadmix Injection
DMSO Aqueous Irrigation Tacrolimus Ophthalmic
This recall does not apply to non-sterile compound products or any other products dispensed by Pallimed.
Based on initial result of the inspection, Pallimed agreed to cease and desist all sterile compounding activities and issue the voluntary recall. Until further notice, Pallimed will not dispense any sterile compound products and will not engage in any sterile compounding activities.
The Board of Registration in Pharmacy, which issued a limited Cease and Desist Order covering only sterile compounding operations, will allow Pallimed to continue other non-sterile compounding activities and sales of non-sterile compound products or other products that are unrelated to sterile compounding operations.
By undertaking this recall action, Pallimed can move forward to ensure that our products will always meet the highest standards of safety and customer expectations.
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.
We thank all of the patients, doctors, and hospitals we serve for their ongoing support and understanding.