Class 4 MHRA Drug Alert – Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe (Laboratoire Aguettant)

Class 4 MHRA Drug Alert – Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe (Laboratoire Aguettant)

February 18, 2019

Drug Alert No: EL (19) A/05
Date Issued: 18th February 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for certain batches of Atropine Sulfate 3mg/10ml Solution for Injection in pre-filled syringe (Laboratoire Aguettant)

Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (Laboratoire Aguettant)

PL 14434/0016

Batch Number Expiry Date Pack Size First Distributed
 6501622*A  04/2020  1 x pre-filled syringe  08/11/2018
 6502640  10/2021  10 x pre-filled syringes  07/01/2019
 6502785  12/2021  10 x pre-filled syringes  Not applicable
 9901362  12/2021  10x pre-filled syringes  Not applicable

Agguettant Healthcare Limited has informed MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of the above product. In section 6 of the leaflet included in these batches, the equivalent content of Atropine base is expressed incorrectly as 0.17mg per ml and 0.83mg in 10ml.

Corrected PIL will state the following:

Each ml of solution for injection contains 0.3mg atropine sulfate monohydrate equivalent to 0.25mg atropine.

Each 10ml syringe contains atropine sulfate monohydrate equivalent to 2.5mg atropine.

In addition to this, minor errors on the Summary of Product Characteristics (SPC) and the carton are also being corrected. In the current versions of both, the equivalent content of Atropine base is expressed as 0.26mg per ml and 2.49mg in 10ml. This is being corrected to give equivalent contents of 0.25mg per ml and 2.5mg in 10ml.

Steps have already been taken to correct the PIL, the SPC and the carton. Distribution of the above batches will cease once corrected stock is available. It is anticipated that new batches will be available in June 2019.

Advice for community pharmacy teams:

Check the batch numbers and be aware the Atropine base may be expressed incorrectly. The correct information is as above and in the alert here.

For medical information enquiries, please contact Aguettant by email: info@aguettant.co.uk or telephone 01275 463691



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