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

Alliance Healthcare News

Class 2 Recall on Desmopressin Nasal Spray (All Strengths)

Ferring Pharmaceuticals Limited is recalling all unexpired stock of the below batches of products from pharmacies and wholesalers as a precautionary measure due to a lower volume of solution being observed in the bottles, and out of specification results for the content of the desmopressin acetate (active substance) and benzalkonium chloride (excipient).

Class 2 Recall on Nitrofurantoin Tablets 50mg

Dr Reddy's Laboratories (UK) Limited is recalling all unexpired stock of the above batch of Nitrofurantoin 50mg Tablets from pharmacies and wholesalers as a precautionary measure due to out of specification results for dissolution during routine stability testing.

Class 2 Recall on Mepacrine Hydrochloride 100 Mg Tablets

BCM Specials Limited has informed us that a number of foreign body particulates including glass and rubber have been found in one of the containers of the Active Pharmaceutical Ingredient (API) used in the manufacture of Mepacrine Hydrochloride 100mg tablets. A small amount of the affected API (comparative to the API present in batch 85641) has been used in the manufacture of batch 85641 Mepacrine Hydrochloride tablets.

Class 4 Caution in Use on Depo-Provera 150mg/Ml Injection (1ml Vial)

Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder) has informed us of a typographical error in active ingredient stated on the label on the vial. The active ingredient should be "medroxyprogesterone acetate" (a long acting contraceptive) however, it is stated as "methylpredinisolone acetate" (a corticosteroid) in error.

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

The affected products' details are as follows:

PIP CodeProduct DescriptionSupplierAffected Batch

Alliance do not stockDepo-Provera 150mg/Ml Injection (1ml Vial)Drugsrus Ltd (distributor) / Tenolol Ltd (MA Holder)AT0604
X44095

Alliance healthcare do not stock this product and as this is a caution in use only we are not accepting stock returns.

For more information or medical information enquiries please contact info@drugsrus.co.uk or call on 020 8423 3800

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 2 Recall on Epistatus 10mg/mL Oromucosal

Torbay Pharmaceuticals has informed us that the child-resistant container closure for Epistatus 10mg/mL Oromucosal Solution (Multi Dose Bottles) may be faulty and incorrectly engaged. The child resistant closure can potentially be removed without unscrewing the cap closure. Removal of an incorrectly engaged cap closure will result in the yellow tamper evident band not being retained on the neck of the bottle. It should be noted that this product is manufactured as an unlicensed special..

Class 4 Caution in use Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection

Torbay Pharmaceuticals has informed us that the carton label on Sodium Benzoate (Amzoate) 2g in 10 mL Sterile Solution for injection incorrectly states the concentration of disodium edetate (excipient) as 0.1% w/v (10mg in 1mL) instead of 0.1% w/v (10mg in 10mL).

Class 2 Recall on Emerade 500 microgram auto-injectors

Pharmaswiss Ceska republika s.r.o. (an affiliate of Bausch & Lomb UK Limited) is recalling all unexpired batches of Emerade 500 microgram auto-injectors (also referred to as pens) from patients due to an error in one component of the auto-injector believed to cause some pens to fail to activate and deliver adrenaline.

Class 4 Caution in Use on GSK various products

GSK has informed us that due to a machinery defect with the printing line, a small number of packs may not have the batch number and expiry date printed on the outer cartons. The correct information is printed on the blister pack and there is no concern with the product quality.

Class 4 Caution in Use on Levofloxacin 500mg Tablets

TEVA UK Limited has informed us that the Product Code/GTIN (PC) number found on the above batches is incorrect. The GTIN number that should have been allocated for this batch of tablets is 05017007064459, however, 05017007064435 was applied in error which scans the batches as Levofloxacin 250mg Tablets. The product packed, the blister primary data, PIL primary data and carton primary data were confirmed as correct for a Levofloxacin 500mg Tablet batch.