Infusion Options Inc. has decided to recall all sterile products lots within expiry date due to lack of sterility assurance. Till date, the company has not received any adverse event report but administration of sterile products whose sterility is not assured can be life-threatening.
Infusion Options Inc. is recalling all their distributed products from the hospital in Brooklyn, N.Y. and notifying their customers by letter and email about the same. They are also making required arrangements for products return.
Consumers are advised to stop using these products immediately and return them to the company for destruction. If they experience any adverse event they should contact their physician or healthcare expert.
Any adverse reaction or quality problems experienced may be reported to the FDA’s MedWatch Adverse Event Reporting program. The U.S. FDA is fully aware about this recall.
Mr Vinod Arora, Principal Advisor, IGMPI
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