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Recall notice for Lipocomb 10 mg/10 mg hard capsules, PPA0465/460/001 and Lipocomb 20 mg/10mg hard capsules, PPA0465/460/002

Notice type: Recall

Date: 15/09/2023

 We wish to advise you that two batches of Lipocomb 10 mg/10 mg hard capsules, PPA0465/460/001 and Lipocomb 20 mg/10mg hard capsules, PPA0465/460/002 are being recalled with immediate effect.

This recall is going to patient level.

The recall is being initiated due to a product mix up issue due to incorrect labelling. It is possible that blisters contained within packs of Lipocomb 10 mg/10 mg hard capsules actually contain Lipocomb 20 mg/10 mg hard capsules. It is also possible that blisters contained within packs of Lipocomb 20 mg/10 mg actually contain Lipocomb 10 mg/10 mg capsules.

Pharmacists can download a copy of the recall letter.
 

Product name or type:
Lipocomb 10 mg/10 mg hard capsules, PPA0465/460/001 and Lipocomb 20 mg/10mg hard capsules, PPA0465/460/002

Serial Or Batch Number And Expiry Date:
For Lipocomb 10 mg/10 mg hard capsules, PPA0465/460/001, batch number on carton 5466A0722::RN220, batch number on blister sticker label 5466A0722, expiry date 07/2025

For Lipocomb 20 mg/10mg hard capsules, PPA0465/460/002, batch number on carton L803D0822::RN228, batch number on blister sticker label L803D0822, expiry date 08/2025

Authorisation Holder:
PCO Manufacturing Ltd.

Prescription Required:
Yes

Recall Classification:
Patient level recall

Target Audience:
Patients and Pharmacists

Actions To Be Taken:
Information for pharmacists:
Pharmacists are requested to carry out the following actions:
1. Immediately quarantine any units from the above batches which you have in your pharmacy or returned to you.

2. Please immediately check your dispensing records to identify patients to whom any packs of the above products were dispensed since 8th August 2023 (Lipocomb 10 mg/10 mg hard capsules) and since 24th August 2023 (Lipocomb 20 mg/10 mg hard capsules).

3. If any patients are identified during this check, please contact the patient or their carer to check if they have an impacted batch in their possession. They should be instructed to check the batch number printed on the carton, or printed on the sticker on the product blisters. Please advise the patient not to use the impacted pack and to return the impacted pack to their pharmacy at their earliest opportunity to obtain a pack from an unimpacted batch.

4. Please contact PCO’s Sales Support Team on 01-8356700 to arrange uplift of quarantined units within the next 14 days.

If you have supplied units of the above batches to another pharmacy or clinic, please forward a copy of the recall letter to them so that they can perform the requested actions.
Should you have any queries in relation to the recall, please contact Niamh Clarke at 01-8356700.
 
Information for patients:
1. Check the batch number printed on the carton, or printed on the sticker on the product blisters.

2. If you have an impacted pack within your possession, do not use the impacted pack. Return the impacted pack to your pharmacy at your earliest opportunity to obtain a pack from an unimpacted batch.

 

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