Product recalls & drug alerts (UK market)

Home > Recalls / Product alerts / Drug alerts | Search

2008  2007  2006  2005  2004  2003  2002  2001

Latest recall/drug alert

30 October

DRUG ALERT:
Salbutamol inhalers more

9 April

Actiq lozenges ... more

PRODUCT ALERTS

DRUG ALERTS

30 October

DRUG ALERT:
Salbutamol inhalers more

DRUG ALERT: Test firing important for certain inhalers (30 October)

The Medicines and Healthcare products Regulatory Agency (www.mhra.gov.uk) has issued a drug alert stating the importance of a “test fire” before using a Generics (UK) salbutamol inhaler for the first time. The alert follows reports of sticking or squeaking valves on first use of the inhaler.

The patient information leaflet states: “It is a wise precaution to test fire before using the aerosol for the first time and also on every occasion when it has not been used for a week or more.” Some units may require several “test fires” before operating smoothly, and in a small number of cases, the valve may take longer than one minute to return after the first actuation, but the dose delivered should not be affected.

Pharmacists are advised to remind patients of the importance of test firing. For further information contact the Generics (UK) medical information department on 01707 853000.

DRUG ALERT: Methotrexate (14 October)

The Medicines and Healthcare products Regulatory Agency has advised caution in use for the following batches of methotrexate injection and tablets in Cyanamid livery because changes in the summary of product characteristics have not been incorporated into the packaging and labels.

Stock with compliant packaging will be available by the end of October. Further details at www.mhra.gov.uk


See also Law and Ethics Bulletin and Good Practice Points

RECALL: Zopiclone 7.5mg tablets (26 September)

The following batches of zopiclone 7.5mg tablets, pack size 28, in Dominion Pharma and Arrow Generics liveries and manufactured by PLIVA Pharma are being recalled because they may not be meet their shelf-life specification.

Recipients of these batches should quarantine any remaining product. PLIVA suggests that pharmacists contact customers to whom they have supplied the product to arrange for return or destruction of remaining stock. Customers should contact their supplier to arrange for credit.

For further information contact PLIVA Pharma on 01730 710900.

RECALL: Adult Meltus for Chesty Coughs and Catarrh (17 September)

The following batch of Adult Meltus for Chesty Coughs and Catarrh is being recalled because of a failure to meet its specification in respect of guaiphenesin and cetylpyridinium chloride (SSL International).

Any remaining product should be quarantined.

For credit and replacement customers can contact A. Knott, Quality Manager, SSL International Distribution Centre, Stakehill Industrial Estate, Finlan Road, Middleton, Manchester M24 5ST.

For general enquiries contact the company’s medical information department on 0161 621 2030.

RECALL: CoaguChek PT test strips (11 September)

The following batch of CoaguChek PT test strips are being recalled because a manufacturing problem has caused a defect in the packaging of the strips that may give rise to falsely high international normalised ratio results (Roche Dignostics).

Any remaining product should be quarantined. Roche suggest that pharmacists identify patients who have been supplied with these strips and advise them to repeat their blood testing with a new batch of strips.

Customers can contact Roche for replacement strips on 01273 484 863.

RECALL: Flucloxacillin 500mg capsules (3 September)

The following batches of Generics (UK) flucloxacillin 28 x 500mg capsules are being recalled because stability test data has indicated that the registered shelf life specifications may not be guaranteed.

Any remaining product of these batches should be quarantined. Customers can contact Generics (UK) to arrange for credit and/or replacement (tel 01707 853100).

RECALL: Baxter products supplied in Viaflo bags (3 September)

All batch numbers of the following products supplied in 250ml, 500ml or 1 litre Viaflo bags manufactured at Thetford are being recalled (Baxter Healthcare). This is because of a potential contamination which may cause the products to have a high pH without exhibiting any physical changes, although particles and/or a colour change may be present.

Products supplied in Viaflex and Viaflo products with codes starting FPE and FUE are not affected. Customers in critical need of these products who have not heard from Baxter should contact the company’s customer services on 01635 206060 or 01635 206161. For technical/clinical information contact Baxter medical information on 01842 767189.

RECALL: Sodium chloride 0.9 per cent intravenous infusion (15 August)

Further to the recall of two batches of Baxter's sodium chloride 0.9 per cent intravenous infusion on 12 August, five further batches have been recalled. The recall notice issued by the Medicines and Healthcare products Regulatory Agency is a Class I recall, which demands immediate action by recipients, even out of hours. Some bags in the affected batches contain white particles and some bags have a high pH.

Any remaining product of these batches should be quarantined. Baxter is contacting customers to arrange for credit or replacement.

For further information contact Baxter Healthcare customer services on 01635 206060 (Northern team) or 01635 206161 (Southern team.)

RECALL: Sodium chloride intravenous infusion (12 August)

The following batch numbers of sodium chloride 0.9 per cent intravenous infusion BP are being recalled because a small number of bags have been reported to contain white particles (Baxter Healthcare Ltd).

Any remaining product of these batches should be quarantined. Baxter is contacting customers to arrange for credit or replacement.

For further information contact Baxter Healthcare customer services on 01635 206060 (Northern team) or 01635 206161 (Southern team.)

RECALL: Eprex pre-filled syringes (12 August)

Batches of the following strengths of eprex (epoetin alfa) solution for injection pre-filled syringes manufactured during 2002 have been recalled because of low level contaminants arising from the rubber stoppers (Janssen-Cilag Ltd).

The company says that there is no evidence of any health risks. Any remaining stock should be quarantined. Janssen-Cilag will be contacting customers to arrange for return or replacement. This recall also applies to some strengths of parallel imports with the same batch numbers from PIE Pharmaceuticals, Concept Medical, Chemlines and Danfleet International.

Further information can be obtained from Janssen-Cilag customer services on 0800 333001.

DRUG ALERT: EpiPen (5 August)

There is a potential discrepancy of expiry dates on EpiPen Auto-injectors (adrenaline 1 in 1000) (ALK-Abelló).

The outer pack and the syringe label carry identical and correct expiry dates. The syringe label can be peeled back to reveal the list of ingredients and a different expiry date may be found printed directly onto the syringe barrel. The correct expiry date is that on the pack and syringe label. This does not affect the quality or safety of the product.

For further information contact ALK-Abelló (tel 01488 686016)

www.alk-abello.com

RECALL: Cox amoxycillin mixture (30 May)

Alpharma has recalled a batch of amoxycillin mixture manufactured by Athlone Laboratories Ltd and packed in Cox livery because the batch has been labelled with a mixture of 125mg/5ml and 250mg/5ml labels.

RECALL: Cetraben emollient cream (30 April)

The following batch of Cetraben emollient cream 500g pump-dispenser has been recalled as a precautionary measure (Sankyo Pharma UK).

This is because the preservative content is out of specification. The stability of the product remains unaffected. Recipients of this batch are requested to embargo any remaining stock and make arrangements for return and replacement via their wholesaler.

Further information can be obtained by telephoning Sankyo Pharma on 01494 766866.

RECALL: Phenylephrine Hydrochloride Minims (30 April)

The following batch of Phenylephrine Hydrochloride Minims 2.5% has been recalled as a precautionary measure (Chauvin Pharmaceuticals)

This is because a small number of complaints have been received regarding leaking Minims. Recipients are asked to quarantine any remaining stock and contact either their supplier or Chauvin Pharmaceuticals in order to make arrangements for return and replacement.

Further information can be obtained by contacting Chauvin Pharmaceuticals on 020 8781 2800.

URGENT RECALL: Actiq lozenges 200 µg, 400 µg, 600 µg, 800 µg and 1600 µg (9 April)

The following batches of Actiq (fentanyl as citrate) compressed lozenge with integral oromucosal applicator have been recalled (Cephalon):

The above batches are being recalled as a precautionary measure to avoid any risk of overdose of fentanyl to patients as some "high potency out of specification" results were found during non-routine product testing. Only a small number of potentially affected lozenges were identified.

Recipients are requested to quarantine all stocks of all affected batches and return them to their supplier for credit. Any packs returned by patients should be destroyed in accordance with the Misuse of Drugs Act and following guidance provided. Further information can be obtained by calling the Cephalon medical information helpline (tel 0800 783 4869).

RECALL: Valium injection 10mg/2ml (28 February)

Roche Products Ltd has recalled two batches of Valium injection 10mg/2ml because follow-up stability testing has revealed visible particles after two years of storage.

Stocks can be returned to suppliers for credit.

For further information contact Roche Customer Services (tel 0800 731 5711), Roche Products Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY.

RECALL: Salivix pastilles (20 February)

Due to labelling anomalies, the following batch of Salivix pastilles for treating dry mouth symptoms is being recalled (Provalis Healthcare):

Stocks of the product should be returned to suppliers.

Details from Provalis Healthcare, Newtech Square, Deeside Industrial Estate, Deeside CH5 2NT (tel 01244 288888).

RECALL: Metrodin High Purity

All suppliers of Metrodin High Purity (urofollitrophin as follicle-stimulating hormone) 75iu and 150iu ampoules are recalling existing stocks of the product as a precautionary measure. Supply of the product is being permanently discontinued with immediate effect. Full batch number details are not currently available for all suppliers, however, stocks of all batches should be quarantined and returned to the supplier as follows:

Serono Recipients are requested to return any packs remaining in stock for credit by 31 March to Serono, c/o UniDrug Distribution Group, South Normanton, Derby, DE55 2FH. Credit claims for reimbursement should be forwarded to customer services at the above address (tel 01773 510123). Questions should be directed to Serono medical information (tel 0800 783 4661).

Other suppliers
Chemilines (tel 020 8799 7600)
Dowelhurst (tel 0800 731 4040)
Global Pharmaceuticals (tel 020 8974 2786)
OPD Laboratories (tel 01923 331409 or 01923 444999)
Primecrown (tel 01895 810787, fax 01895 812306)
Stephar (UK) (tel 01493 650069)
Swinghope (tel 020 8675 6918)
Swingward (tel 020 8523 5500)
Waymade (tel 01268 535222)

RECALL: Erwinase (crisantaspase/asparaginase) 10,000 units/vial (6 February)

Ipsen Biopharm is recalling all of the following batches of Erwinase (crisantaspase/asparaginase) 10,000 units/vial, manufactured by CAMR, Porton Down.

The recall is a precautionary measure following a review of process revalidation results relating to product sterility assurance. All of the batches met specifications at the time of release. Stocks should be quarantined and returned to Ipsen Biopharm, Ash Road, Wrexham Industrial Estate, Wrexham LL13 9UF.

Further details from John Johnson, quality assurance manager, Ipsen Biopharm, on 01978 661181.