PMI System News Feed

Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery

Tue, 07 Sep 2010 14:01:19 GMT

Action within 5 days - Teva UK Limited and Generic Glibenclamide 5 mg Tablets EL (10)A/17

Further to the Drug Alert issued by the MHRA on 15 March 2010 (EL (10)A/06 Rev 1) concerning the recall of some batches of this product due to issues with tablet dissolution during routine stability testing, Teva UK Limited has informed us that is has now received new stock.

Sandoz Ltd - Temozolomide Capsules - EL (10)A/16

Tue, 07 Sep 2010 14:01:19 GMT

Class 1 Drug Alert (Action now - including out of hours): Sandoz Ltd - Temozolomide Capsules - EL (10)A/16 Sandoz Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.

Hospira UK Ltd - Temozolomide Hospira Capsules - EL (10)A/15 (Action now - including out of hours)

Tue, 07 Sep 2010 14:01:19 GMT

Hospira UK Ltd is recalling the above batches to patient level due to reports of broken capsules and leakage. We understand this product is normally supplied via hospitals and not from general practitioners or community pharmacy.

Pharmacists and clinics are requested to contact patients and ask them to return any stock of the above batches without further opening of the containers. If external contamination of the containers is suspected handle whilst wearing latex or nitrile gloves. Place the container in a polyethylene bag and seal prior to return.

Goldshield Pharmaceuticals - Phenindione 25 mg Tablets

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Goldshield Pharmaceuticals - Phenindione 25 mg Tablets - EL (10)A/14

Goldshield Pharmaceuticals is recalling the above batch because some tablets within the batch are showing a dark orange/brown discolouration. The tablets are normally green. The cause of the discolouration is under investigation.

Since Goldshield Pharmaceuticals is the single source of this product, there may be supply issues. This is at present being addressed by the company.

Aurum Pharmaceuticals Limited - Acetylcysteine 200mg/ml Injection

Tue, 07 Sep 2010 14:01:19 GMT

Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals Limited Acetylcysteine 200mg/ml Injection EL(10)A/13

Ranbaxy (UK) Limited - Gabapentin 100mg Capsules

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Ranbaxy (UK) Limited - Gabapentin 100mg Capsules - EL (10)A/12

Therabel Pharma UK Ltd - Dyloject Vials 75 mg/2 ml

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Therabel Pharma UK Ltd - Dyloject Vials 75 mg/2 ml - EL (10)A/11

Ranbaxy (UK) Limited - Mirtazapine 15 mg and 45 mg Tablets

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Ranbaxy (UK) Limited - Mirtazapine 15 mg and 45 mg Tablets - EL (10)A/10

Class 3 Drug Alert (Action within five days): Landmark Pharma Limited Timoptol 0.5% Ophthalmic Solution, 5 ml (Timolol Maleate 0.5% Ophthalmic Solution) - EL (10)A/07

Tue, 07 Sep 2010 14:01:19 GMT

Landmark Pharma Limited is recalling all unexpired stock of the above parallel imported product because of errors on the carton label, as follows:

Class 2 Drug Alert (Action within 48 hours): P.I.E. Pharma Limited and Star Pharmaceuticals Limited - Multiple product Drug Alert, parallel imports - EL (10)A/08

Tue, 07 Sep 2010 14:01:19 GMT

P.I.E. Pharma Limited / Star Pharmaceuticals Limited are recalling unused stock from batches of products with the PLPI numbers shown above and with expiry dates within the stated ranges because the patient information leaflet (PIL) has not been updated to include mandatory safety warnings issued by the European Medicines Agency.

Class 2 Drug Alert (Action within 48 hours): Acino Pharma GmbH - Clopidrogel 75 mg Tablets - EL (10)A/09

Tue, 07 Sep 2010 14:01:19 GMT

Acino Pharma GmbH are recalling several batches of the Clopidrogel 75 mg tablets due to concerns about Good Manufacturing Practices (GMP) at the production site for the active pharmaceutical ingredient.

Class 3 Drug Alert (Action within five days): Teva UK Limited - Glibenclamide 5mg Tablets in Teva UK Limited and Generics UK Limited Livery - EL (10)A/06 Rev 1

Tue, 07 Sep 2010 14:01:19 GMT

This Drug Alert replaces Drug Alert EL (10)A/06, issued on 9 March, as additional batches involved in the recall have been identified.

Teva UK Ltd - Glibenclamide 5 mg tablets

Tue, 07 Sep 2010 14:01:19 GMT

Class 3 Medicines Recall (Action within five days): Teva UK Limited - Glibenclamide 5 mg Tablets in Teva UK Limited and Generics (UK) Limited Livery - EL (10)A/06

Class 2 Drug Alert: Winthrop Pharmaceuticals UK Ltd Alimemazine Tartrate 7.5 mg/5 ml Syrup - EL (10)A/04

Tue, 07 Sep 2010 14:01:19 GMT

Winthrop Pharmaceuticals UK limited is recalling all remaining stocks of a certain batch of Alimemazine Tartrate 7.5 mg/5 ml Syrup. This action is being taken as a precautionary measure because the company has become aware that there is the potential for a bottle of 30 mg/5 ml syrup to be found in a carton labelled for 7.5 mg/5 ml syrup. To date, only one such pack has been identified.

Class 2 Drug Alert (Action within 48 hours): AstraZeneca UK Ltd - Citanest 1% solution for injection, multi-dose vials 10mg/ml, prilocaine hydrochloride - EL (10)A/03

Tue, 07 Sep 2010 14:01:19 GMT

AstraZeneca UK Ltd is recalling all remaining stock of batches of the above product expiring before the end of 2011. This action is being taken because routine stability testing has indicated that the preservative levels may become too low after 24 months from manufacture.

Class 2 Drug Alert (Action within 48 hours): DDD Limited - Dentinox Teething Gel - EL (09)A/34

Tue, 07 Sep 2010 14:01:19 GMT

DDD Limited is recalling certain batches of Dentinox Teething Gel due to the presence of very small amounts of a contaminant, Glyoxal, in the product.

Chefaro UK Ltd - Metatone

Tue, 07 Sep 2010 14:01:19 GMT

Chefaro UK Limited is recalling a batch of Metatone due to the presence of very small amounts of petrol found in this product. The company has not received any reports of adverse reactions associated with this batch.

Pinewood Laboratories Limited - Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, Peptac Liquid Aniseed Flavour - EL (09)A/30

Tue, 07 Sep 2010 14:01:19 GMT

Pinewood Laboratories Limited is carrying out a precautionary recall on three medicines, Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid (Ivax Pharmaceuticals UK) and Peptac Liquid Aniseed Flavour (Ivax Pharmaceuticals UK) due to a low-level bacterial contamination detected in three batches.

Gaviscon Advance Peppermint Flavour

Tue, 07 Sep 2010 14:01:19 GMT

Reckitt Benckiser is carrying out a precautionary medicine recall at wholesale and pharmacy level, on two batches of 500ml bottles of Gaviscon Advance Peppermint Flavour; batch numbers 924471 and 925071.

Abraxis batch number update

Tue, 07 Sep 2010 14:01:19 GMT

The batch number quoted in Friday's drug alert which was checked by the company has now been reported as incorrect. Please ignore the communication sent yesterday and replace it with this document.

Abraxis BioScience Ltd - Abraxane 5mg/ml powder for suspension for infusion

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Abraxis BioScience Ltd - Abraxane 5mg/ml powder for suspension for infusion - EL (09)A/28

Fluconazole 2mg/ml solution for infusion

Tue, 07 Sep 2010 14:01:19 GMT

Class 4 Drug Alert (caution in use): Focus Pharmaceuticals Limited - Fluconazole 2mg/ml Solution for Infusion – EL (09)A/27

Class 2 Drug Alert - Cervarix (human papillomavirus vaccine)

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): GlaxoSmithKline Biologicals sa - Cervarix (human papillomavirus vaccine) – EL (09)A/26Class 2 Drug Alert (Action within 48 hours): GlaxoSmithKline Biologicals sa - Cervarix (human papillomavirus vaccine) – EL (09)A/26

Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Ltd - Multiple product Drug Alert - EL (09)A/23

Tue, 07 Sep 2010 14:01:19 GMT

Karib Kemipharm (also trading as Karib Ltd) is carrying out precautionary medicine recalls at wholesale and pharmacy level. This follows evidence that the medicines, contract manufactured in India, were exposed to unsatisfactory conditions during shipment by sea, potentially causing them to deteriorate over time.

Class 4 Drug Alert (Caution in use): Solvay Healthcare Limited - Creon Micro Pancreatin 60.36mg Gastro-resistant Granules - EL (09)A/22

Tue, 07 Sep 2010 14:01:19 GMT

Solvay Healthcare Limited has informed the MHRA that the lid on bottles of Creon Micro Pancreatin 60.36mg Gastro-resistant Granules from the above batch may spontaneously open, either fully or partially. The product is only affected once the tamper evident strip has been removed.

Strandhaven Ltd - UPDATE

Tue, 07 Sep 2010 14:01:19 GMT

Strandhaven Limited have now informed the MHRA that the affected Amlodipine 5mg and 10mg Tablets are presented in Somex Pharma livery.

Amlodipine - Jubilant Pharma NV and Wockhardt UK Ltd

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): Jubilant Pharmaceuticals NV and Wockhardt UK Ltd - Amlodipine 5mg and 10mg Tablets - EL (09)A/15

Class 2 Drug Alert (Action within 48 Hours): Milpharm Limited - Fluoxetine 20mg Capsules - EL (09)A/17

Tue, 07 Sep 2010 14:01:19 GMT

Milpharm Limited are recalling all unexpired stock of the above product in Karib Kemi Pharm Limited livery only (batches beginning with ‘T’) due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of their contract manufacturer.

Class 2 Drug Alert (Action within 48 hours): Karib Kemi Pharm Limited - Multiple Product Drug Alert - Doxazosin 2mg and 4mg Tablets; Fluoxetine 20mg Capsules - EL (09)A/18

Tue, 07 Sep 2010 14:01:19 GMT

Karib Kemi Pharm Limited are recalling the above products due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of their contract manufacturer.

Class 2 Drug Alert (Action within 48 hours): Strandhaven Limited - Amlodipine 5mg and 10mg Tablets - EL (09)A/21

Tue, 07 Sep 2010 14:01:19 GMT

Strandhaven Limited are recalling the above products due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of their contract manufacturer.

Class 2 Drug Alert (Action within 48 hours) : Sandoz Limited - Multiple Product Drug Alert - Baclofen 10mg Tablets; Fluoxetine 20mg Capsules and Metformin 500mg and 850mg Tablets - EL (09)A/20

Tue, 07 Sep 2010 14:01:19 GMT

Sandoz Limited are recalling the above products due to serious Good Manufacturing Practice (GMP) deficiencies found during an inspection of one of their contract manufacturers.

Multiple Products - LPC Medical Ltd

Tue, 07 Sep 2010 14:01:19 GMT

Class 2 Drug Alert (Action within 48 hours): LPC Medical (UK) Limited - Multiple Product Drug Alert - Co-Amilozide 5/50 Tablets; Metformin 500mg and 850mg Tablets; Naproxen 250mg and 500mg Tablets - EL (09)A/19

Amlodipine 5mg and 10mg tablets

Tue, 07 Sep 2010 14:01:19 GMT

Greystone Ltd are recalling tablets due to serious GMP deficiencies found during an inspection of their contract manufacturer.

Amlodipine 5mg and 10mg tablets

Tue, 07 Sep 2010 14:01:19 GMT

Jubilant Pharmaceuticals NV, the product marketing authorisation holders, are recalling products due to serious GMP deficiences.

#drug alert 1# Oxybutynin Hydrochloride Tablets 5mg

Tue, 07 Sep 2010 14:01:19 GMT

Niche Generics Ltd, the product marketing authorisation holder, are recalling stock due to the possible inclusion of undispersed active ingredient which has the potential to result in patient overdose. The above marketing authorisation number has been used for stock distributed in Niche Generics and Actavis liveries.

Drug Alert - Sinepin capsules 50mg

Tue, 07 Sep 2010 14:01:19 GMT

There is an error in the Braille print on the carton of a batch of Sinepin (doxepin; Marlborough Pharmaceuticals) capsules 50mg. The print embossed on the carton incorrectly says 'Sinepin 25mg' when it should say 'Sinepin 50mg'. The affected batch of cartons, containing 28 capsules, has an expiry date of 01/2012 and the batch number 0901001 and was first distributed on 25 March 2009.

http://www.mhra.gov.uk/Publications/Safetywarnings/Drugalerts/CON046482