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.

Class 4 Caution in Use on Paracetamol 250mg/5ml Oral Suspension

Rosemont Pharmaceuticals Ltd has informed us of an error in the barcode and GTIN number of the label on the bottle of the above batches. When scanned, the barcode identifies the bottle as Paracetamol 120ml/5ml Oral Suspension instead of Paracetamol 250mg/5ml Oral Suspension. The dm&d browser website also identifies this GTIN number and barcode incorrectly as Paracetamol 120ml/5ml Oral Suspension.

Class 4 Caution in Use on Zamadol SR 50 mg prolonged-release hard capsules

Mylan UK Healthcare Ltd has informed us that the GTIN barcode applied on the above batches is incorrect. The GTIN number that should have been allocated for these batches of capsules is 05060035240173, however, 05060035241477 was applied in error which scans the batches as Zamadol Melt Tablet 50mg. All other information on the carton and label, including the EAN barcode is correct for the above batches of Zamadol SR 50 mg prolonged-release hard capsules.

Class 2 Recall on Esmya Tab 5mg

Gedeon Richter (UK) Ltd is recalling all unexpired stock of the above products from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine. To protect patients while a safety review is conducted, the European Medicines Agency's safety committee, Pharmacovigilance Risk Assessment Committee, (PRAC) has recommended that women stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids.