Class 4 defect information: Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe. (MDR 18-01/19)
Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
Product information
MDR number
MDR 18-01/19
Company name
Laboratoire Aguettant
Product description
Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
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 |
Brief description of the problem
Aguettant Limited has informed the MHRA that there is an error in the Patient Information Leaflet (PIL) for batches of the above product listed above. 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 in10ml.
The 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 in10ml. 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.
Company contact information
For all enquiries, including medical information enquiries, please contact [email protected], or telephone 01275 463691
Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.
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