Class 4 MHRA Drug Alert – Ativan 4mg/1ml Solution for injection (Lorazepam) (Pfizer Limited) Caution in use

Class 4 MHRA Drug Alert – Ativan 4mg/1ml Solution for injection (Lorazepam) (Pfizer Limited) Caution in use

April 24, 2019

Drug Alert No: EL (19) A/10
Date Issued: 24th April 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Ativan 4mg/1ml Solution for Injection (Lorazepam) (Pfizer Limited)

Ativan 4mg/1ml Solution for Injection (Lorazepam) (Pfizer Limited)

PL 00057/1279

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  Not applicable

Pfizer Limited has informed MHRA that the text on the carton label for the above product has recently been updated and at this time, 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.

The size of the ampoules (2ml) has not changed and the label on the ampoules remains unchanged and states ‘4mg in 1ml’

MHRA understands that the carton label is in the process of being revised to reflect the volume of solution contained in the ampoules and batches with the revised labels are expected to become available during Q3 2019.

Advice for community pharmacy teams:

View the full alert here
For further information, please contact Pfizer Medical Information, tel: 01304 616161

 



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