We want to bring to your attention an urgent recall affecting two specific batches of Lipocomb capsules, Lipocomb 10 mg/10 mg (batch PPA0465/460/001) and Lipocomb 20 mg/10 mg (batch PPA0465/460/002). This recall is being executed at the patient level due to a product mix-up issue stemming from incorrect labeling. It is imperative that patients and pharmacists take immediate action to ensure safety and accuracy in medication usage.

Product Details and Recall Information:

• 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

• 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

Authorized Holder: PCO Manufacturing Ltd.

Prescription Required: Yes

Recall Classification: Patient-level recall

Target Audience: Patients and Pharmacists

Actions To Be Taken:

For Pharmacists:

1. Immediate Quarantine: Isolate any units from the specified batches in your pharmacy or those returned to you.

2. Dispensing Records Check: Review your dispensing records to identify patients who received packs of the affected products since 8th August 2023 (Lipocomb 10 mg/10 mg) and since 24th August 2023 (Lipocomb 20 mg/10 mg).

3. Patient Contact: Get in touch with identified patients or their caregivers. Advise them to check the batch number on the carton or blister sticker. Instruct them not to use the affected pack and to return it to your pharmacy for replacement from an unaffected batch.

4. Contact PCO’s Sales Support Team: Call 01-8356700 to arrange the uplift of quarantined units within the next 14 days.

For Patients:

1. Check Batch Number: Inspect the batch number on the carton or the sticker on the product blisters.

2. Do Not Use Affected Pack: If you have a pack from the impacted batches, refrain from using it. Return it to your pharmacy as soon as possible to receive a replacement from an unaffected batch.

Further Assistance: For any queries related to the recall, please reach out to Niamh Clarke at 01-8356700.

Read more about this recall here:

http://www.hpra.ie/homepage/medicines/safety-notices/item?t=/recall-notice-for-lipocomb-10-mg-10-mg-hard-capsules-ppa0465-460-001-and-lipocomb-20-mg-10mg-hard-capsules-ppa0465-460-002&id=b7d81426-9782-6eee-9b55-ff00008c97d0