Ticker Update

Class 2 Recall on Phosphates Solution For Infusion 500ml

Huddersfield Pharmacy Specials (HPS) is recalling the above batches of phosphates solution for infusion due to observation of precipitation in batch 500609X. The decision to recall all other batches has been made as a precautionary measure.

Class 2 Recall on Clexane 4,000 Iu (40mg) /0.4ml Syringes

Pharmaram Ltd has informed us that the below batch of Clexane 4,000IU (40mg)/0.4ml syringes has an error on the labelling affixed to the plastic blister packaging encasing the syringe. The label incorrectly states "Clexane 6,000IU (60mg)/0.6ml Syringes", when it should have stated "Clexane 4,000IU (40mg)/0.4ml Syringes". The outer carton states the correct strength; the batch number and expiry dates are also correct and match the details on the labelling.

Class 4 Caution in Use on SyreniRing 0.120 mg/0.015 mg per 24 hours, vaginal delivery system

Crescent Pharma Ltd has informed us that the Patient Information Leaflet (PIL) within the packs for the below batches is missing important safety relevant text changes.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch

4091625SYRENIRING 0.12MG/0.015MG 24 HRCRESCENT PHARMA LTDLF18276AA
LF18894AA

This may have been supplied by AHDL. Unfortunately we are not providing specific batch information you will be required to follow the instructions as per the drug alert.

This is a caution in use only we are not accepting stock returns.

For more information or medical information queries, please contact: Crescent Pharma Ltd. Medical Information Department on +00351 214643225, via email on tiago.barca@pharsolution.com or +44 (0) 1256 772740.

Recipients of this Drug Alert should bring it to the attention of relevant contacts.

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 3 Recall on Digoxin Tab 250mcg

Accord-UK Ltd has informed us of an issue related to decommissioning of the above batch. Upon decommissioning at the pharmacy, there have been reports stating that when scanning the serialised 2D code, the status of packs may report as ‘EXPORT.' Although there is no risk to product quality, any remaining stock should be quarantined and returned.

Class 2 Recall on Abstral Tab 200mcg (Schedule 2 CD)

Kyowa Kirin Limited is recalling the above batch as a precautionary measure, due to the reports of double tablets in a single blister pocket. This was identified during reference sample inspection and there is a potential low risk of accidental double dosage.

Class 3 Recall on Irinotecan Vial 20mg/Ml

Accord Healthcare Limited is recalling the above batch as a precautionary measure, due to the observation of precipitation in the solution in the same batch marketed in another country (Malta). No complaints or adverse reaction reports have been received by the company to date for the UK product.

Class 4 Caution in Use on Ecalta 100mg Powder For Concentrate For Solution For Infusion

Pfizer Limited has informed us that the packs for the above batches have not been packaged with the current version of the Patient Information Leaflet (PIL) containing updated storage instructions of the infusion solution in section 5.

Class 4 Caution in Use on Ibuprofen 200mg And 400mg Tablets

Aspar Pharmaceuticals Limited has informed us that the Patient Information Leaflets (PILs) within the ibuprofen packs below are missing some information identified from post-marketing experience that should be documented in Section 3 (How To Take The Tablets) and Section 4 (Possible Side Effects) of the PIL.

If you have any questions, then please contact your local Service Centre Customer Services team.

Class 4 Caution in Use on Trimogal 100mg And 200mg Tablets

Ennogen Pharma Limited has informed us that the Patient Information Leaflets (PILs) within the packs for the affected batches below contain an error in Section 3 (How To Take Trimogal Tablets) with regard to the dosage instructions for children under 6 years.

Recall on PHE TYPE IIR FACEMASKS

Although these masks meet the breathability, filtration and splash resistance requirements of BS EN 14683, in light of ongoing monitoring, further complaints reported and testing from the manufacturer on the masks. There is a risk to staff wearing the mask if the foam strip on the mask flakes and enters their airway or mouth. There have also been complaints of the ties and/or stitching coming away from the mask.

Please return all affected stock to Alliance Healthcare for replacement stock only. No credit will be issued as part of this Recall. Replacement stock will be issued once received from Department of Health and Social Care.

Please ensure that all stock is returned by Wednesday 22nd of July 2020 any stock returned after this date will not be eligible for replacement.

The affected products' details are as follows:

_{Recipients of this Drug Alert should bring it to the attention of relevant contacts.}

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

If you have any questions, then please contact your local Service Centre Customer Services team.

Annex 1 – Lot numbers of BWM028 Cardinal Type IIR masks 0120GLP09 0517CLP10 0302FLP09 0517JLP09 0305HLP09 0518CLP10 0310GLP09 0518LLP09 0321FLP09 0518LLP09 0321FLP09 0519ALP10 0327FLP09 0519KLP09 0402HLP09 0519MLP09 0408HLP09 0520CLP10 0411FLP09 0520JLP09 0411HLP09 0520LLP09 0413HLP09 0521KLP09 0416HLP09 0521MLP09 0419HLP09 0522ALP10 0422HLP09 0522LLP09 0425HLP09 0523CLP10 0428HLP09 0523JLP09 0431HLP09 0523MLP09 0501ALP10 0524KLP09 0502BLP10 0524LLP09 0502CLP10 0525ALP10 0502LLP09 0525JLP09 0503DLP10 0526CLP10 0503JLP09 0526LLP09 0503KLP09 0526MLP09 0504ALP10 0527KLP09 0504LLP09 0528JLP09 0505BLP10 0528LLP09 0506ALP10 0529CLP10 0506JLP09 0529KLP09 0506KLP09 0529MLP09 0506LLP09 0530JLP09 0508DLP10 0531CLP10 0508KLP09 0531KLP09 0508MLP09 0509JLP09 0510KLP09 0511ALP10 0511JLP09 0511MLP09 0513ALP10 0513KLP09 0513MLP09 0514JLP09 0516ALP10 0516KLP09 0516MLP09

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