Class 4 defect information – Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml

18 Feb 2019

A Class 4 defect information alert has been issued by the MHRA for certain batches of Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml by Aguettant Limited

DRUG ALERT

Class 4 defect information

MDR 18-01/19

18 February 2019

 

Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml

(Manufactured by Aguettant Limited)

PL 14434/0016

 

A Class 4 defect information alert has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for certain batches of Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml as follows:

Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml

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 10 x pre-filled syringes Not applicable

 

Description of alert:

The following errors appear on the literature for the above batches of Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml:

Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml (PL 14434/0016) literature Incorrect information Correct information
Patient information leaflet (PIL) Equivalent content of atropine base is incorrectly stated as 0.17mg per ml and 0.83mg in 10ml 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
Summary of Product Characteristics (SPC) and product carton Equivalent content of atropine base is incorrectly stated as 0.26mg per ml and 2.49mg in 10ml The correct equivalent content of atropine base is 0.25mg per ml and 2.5mg in 10ml

 

 

Supply information:

Supplies of Atropine sulfate solution for injection in pre-filled syringe 3mg/10ml, including those listed above, will continue to be distributed until Aguettant Limited release stock with the corrected literature. Batches containing the corrected information are expected to be available from June 2019.

 

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

Produced by the NPA Pharmacy Services team February 2019.