Ranitidine- All Formulations Supply Disruption 

Source: Medicines & Healthcare Products Regulatory Agency (MHRA)

 

Summary 

  • Further to the previous ranitidine supply disruption alert (SDA/2019/005) issued on 15 October 2019, this is an update on the supply status of both ranitidine oral and injectable products.

 

  • As investigations into ranitidine have progressed, the Medicines and Healthcare products Regulatory Agency (MHRA) have instructed suppliers of both oral and injectable ranitidine in the UK to quarantine all affected, unreleased stock at manufacturer level whilst their investigations are ongoing.

 

  • Ranitidine tablets, effervescent tablets and oral solution are expected to be out of stock with no date for resupply until further notice.

 

  • Ranitidine injection is now also expected to be out of stock imminently with no date for resupply until further notice.

 

  • Extremely limited supplies remaining in wholesalers and pharmacies, which have not been recalled by the MHRA, are available and can be supplied.

 

  • No new patients should be initiated on treatment with ranitidine oral or injectable products.

 

  • All patients should be reviewed as repeat prescriptions are requested and if ongoing treatment is required, be switched to clinical alternatives.

 

Action

All healthcare professionals in primary, secondary or specialist healthcare services who prescribe or supply ranitidine should consider the following advice to manage affected patients.

 

Deadline for actions

Action initiated: On receipt of this alert

Actions completed: 28 February 2020

 

» Click here to read the full CAS alert

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Class 2 Drug Alert- Medicines Recall

Source: Medicines & Healthcare Products Regulatory Agency (MHRA)

 

Paracetamol 500 mg tablets, 1 x1000 (PL 04077/0001)

 

Summary

M & A Pharmachem is recalling all unexpired batches as a precautionary measure, because a small number of pots from some batches have been found to contain discoloured tablets due to fungal contamination. The fungus has been identified as Penicillium citrinum. It is unlikely that any affected tablets will have got to patient level as the discolouration is noticeable on opening affected packs.

 

Advice for healthcare professionals

Stop supplying the above product immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

 

» Click here to read the full CAS alert