Class 2 medicines recall – Action within 48 hours – Bisacodyl Gastro-Resistant tablets 5mg (Chanelle Medical)

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a specific batch of Bisacodyl Gastro-Resistant tablets 5mg manufactured by Chanelle Medical.

DRUG ALERT

Class 2 medicines recall  – Action within 48 hours – Bisacodyl Gastro-Resistant tablets 5mg

Ref: EL (19)A/18

Date 24 July 2019

Bisacodyl Gastro-Resistant tablets 5mg

(Manufactured by Chanelle Medical)

PL 13931/0005

A Class 2 medicines recall has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for a specific batch of Bisacodyl Gastro-Resistant tablets 5mg manufactured by Chanelle Medical.

The manufacturer has recalled the batch because a small number of affected packs contain tablets which are stuck together. In addition, mould has been found on some tablets, this has been identified to be a Penicillium species. It is considered unlikely that patients would have received affected tablets because sticking is evident when the pack is opened.

Pharmacy teams should:

• Immediately stop supplying tablets from the affected batches, quarantine all remaining stock and return it to the supplier using the approved process
• Be aware that although only the above batch has been recalled, a number of batches were manufactured at the same time
  • Notify Chanelle Medical and return (to the supplier) any other batches affected by tablets which are stuck together or where mould can be seen

• Ensure that all medicines are stored within manufacturers’ storage requirements as stated in the Summary of Product Characteristics (SPC)
  • The SPC for Bisacodyl Gastro-Resistant tablets 5mg states “Do not store above 25°C. Store in the original container. Keep the container tightly closed (for polypropylene container only)”

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

Produced by the NPA Pharmacy Services team July 2019.