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Important – Class 4 Alert

We have just been alerted to this packaging issue with Priadel 400mg Prolonged Release. The labelling on the rear panel of the cartons are wrong. On the side of the box where you place the dispensing label, you have Lithium Carbonate 200mg incorrectly printed on it.

Please find more details on the MHRA site below:

http://www.mhra.gov.uk/Publications/Safetywarnings/Drugalerts/CON031161

Webmaster
bookapharmacist.com

Update:
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We are concerned about the above and we have placed a video of the pack affected on our site for the perusal of our members. http://video.google.com/a/bookapharmacist.com/#/Play/contentId=55db6cff26cb0bb

About Lithium Carbonate
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Lithium Carbonate is an effective drug for treating mania, bipolar disorders, and recurrent depression, aggressive or self-mutilating behaviour (BNF).

Because of a narrow therapeutic concentration of 0.4-1mmol/l 12 hours after a dose on days 4-7 treatment and the ‘nasty’ toxic effects, therapeutic drug monitoring is essential when treating a patient with lithium.

We need to be doubly careful when dispensing a drug like lithium. There is the risk that the 400mg dose can be dispensed instead of a 200mg dose especially because in this case, the error occur on the side of the box where you affix the final dispensing label (see video). This risk is however mitigated by the following facts:

  • The shape of the 200mg and 400mg tablets are different and patients will most probably notice and query this difference.
  • The rest of the labelling on the box is correct. Only the side where the label is to be affixed is wrong.
  • Only a small batch is affected.

We are sure Sanofi will take this problem seriously and will institute a check of their QA process to avoid the repeat of this in the future.

Webmaster
bookapharmacist.com

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