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We note that the clarification we are making in this final rule as to injectable drugs with a labeled volume of 2 mL or less as single-dose containers applies only to those without package type terms or explicit discard statements in their product labeling

Xu D, Zhu H, Wang C, Zhu X, Liu G, Chen C, et al

by the year 2000, the FDA had received 1000 injury reports, often attributed to misuse, abuse or mislabeling of the product

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(Oxf.) 83 , 314 (2015)