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Reconstituting with sterile water for single-use sessions can determine whether the preservative causes the problem

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Sun, Y., Qin, H., Zhang, H., Feng, X., Yang, L., Hou, X., & Chen, J

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In these situations, there is "reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death." Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences