The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday issued a class 4defect information regarding Atropine Sulfate 3mg/10ml Solution for injection in pre-filled syringe.
Aguettant Limited has informed MHRA that there is an error in the Patient Information Leaflet (PIL) for the batches 6501622*A, 6502640, 6502785 and 9901362. In section 6 of the Leaflet included in these batches, the equivalent content of Atropine base is incorrectly mentioned as 0.17mg per ml and 0.83 mg in 10ml.
Each ml of solution for injection originally contains 0.3mg atropine sulfate monohydrate equivalent to 0.25mg atropine and each 10ml syringe originally contains atropine sulfate monohydrate equivalent to 2.5mg atropine.
The Summary of Product Characteristic (SPC) and the carton also have minor errors. The current versions of both SPC and Carton, the equivalent content of Atropine base is expressed as 0.26mg per ml and 2.49mg in 10 ml. This is being corrected to give equivalent contents of 0.25mg per ml and 2.5mg in 10ml.
According to MHRA, steps to correct the PIL, SPC and Carton have already been taken and distribution of the above batches will cease once corrected stock is available.
The new batches are expected to be available in June 2019.

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