Class 4 drug alert – Caution in Use – Ativan solution for injection 4mg/1ml

24 Apr 2019

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Ativan® solution for injection 4mg/1ml

DRUG ALERT

Class 4 drug alert – Caution in Use – Ativan solution for injection 4mg/1ml

Ref: EL (19)A/10

Date 24 April 2019

 Ativan solution for injection 4mg/1ml

(Manufactured by Pfizer Limited)

PL  00057/1279

A Class 4 drug alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Ativan® solution for injection 4mg/1ml as shown in the table below.

Batch Number Expiry Date Pack Size First Distributed
4091 Oct 2019 10 x 1ml 15 Apr 2019
4092 Dec 2019 10 x 1ml 10 Apr 2019
4094 Dec 2019 10 x 1ml NA

Pfizer Limited has informed the MHRA that the text on the carton label has been updated to indicate the size of the ampoules; the text has been changed from 10 x 1ml ampoules to state 10 x 2ml ampoules. There have been no changes to the concentration and total volume of the ampoules.

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy Services team April 2019.