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Ativan inj. labelling issue

Three batches affected

April 25th 2019

Tagged: MHRA alert


Pfizer has advised of a labelling issue relating to Ativan 4mg/1ml solution for injection (lorazepam).

The affected batches are: (nos) 4091, exp. October 2019, and 4092/94 with expiry in December 2019.

In an update the product description on the carton was changed from 10 x 1ml ampoules to 10 x 2ml ampoules. The updated text reflects the size of the ampoules, which is 2ml.

The concentration and total volume of the ampoules has not changed and remains 4mg lorazepam in 1ml of solution.  Neither has the size of the ampoules (2ml) changed and the label on the ampoules remains unchanged and states ‘4mg in 1ml’.

Pfizer has advised that the carton label is in the process of being revised to reflect the volume of solution contained in the ampoules and batches: revised labels are expected to become available during Q3 2019.

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