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.