Recalled products (2002)

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19 July 2002

Adsorbed diphtheria and tetanus vaccine for children ...[more]

17 December 2002

Amiodarone hydrochloride ampoules ... [more]

10 August 2002

Amoxicillin capsules and flucloxacillin capsules ... [more]

13 August 2002

BCG vaccines ... [more]

27 February 2002

Beclomethasone dipropionate inhalers ...[more]

26 July 2002

Becotide, Becloforte and Ventide metered dose inhalers ...[more]

23 May 2002

ClinOleic and Ivelip emulsions for infusion ...[more]

16 May 2002

Cytosar, Pharmorubicin and doxorubicin injection ...[more]

19 September 2002

Dilzem XL 240mg capsules ...[more]

29 May 2002

Extraneal peritoneal dialysis solution ...[more]

31 May 2002

Farley's sunrise banana cereal ...[more]

18 April 2002

Hydralazine 25mg tablets... [more]

27 March 2002

Medinol Over 6 oral suspension ...[more]

13 June 2002

Mixtard 30 Innolet ...[more]

17 December 2002

Neomercazole tablets ... [more]

27 February 2002

Phenoxymethylpenicillin 250mg tablets ...[more]

10 October 2002

Salbulin inhaler CFC-free 100mcg/inhalation ...[more]

PRODUCT ALERTS

DRUG ALERTS

RECALL: Amiodarone hydrochloride ampoules (17 December)

The following batches of amiodarone hydrochloride 50mg/ml sterile concetrate ampoules, delivered in the livery of Faulding Pharmaceuticals, have been recalled (Mayne Pharma):

It was found during routine stability testing that these batches may be out-of-specification for free iodides before the end of their shelf-life. Recipients are requested to quarantine stocks of these batches and return them to their supplier for credit or replacement.

Further information can be obtained from medical information, Mayne Pharma, Queensway, Royal Leamingtom Spa, Warwickshire CV31 3RW (tel 01926 821010).

RECALL: Neomercazole tablets (17 December)

The following batches of Neomercazole (carbimazole) 20mg tablets have been recalled (Roche Products):

These batches have been found to contain up to 20 per cent of sub-potent tablets which may be as little as half the strength stated on the label. Recipients are requested to quarantine stocks of these batches and return them to their supplier for credit or replacement.

Further information can be obtained from Roche customer services, Roche Products, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY (tel 0800 731 5711).

RECALL: Salbulin inhaler CFC-free 100mcg/inhalation (10 October)

The following batches of Salbulin (salbutamol) CFC-free inhaler 100mcg/inhalation have been recalled as a precautionary measure (3M Health Care Ltd):

There is a possibility of higher doses (up to 3–5 times greater) being delivered because of a faulty valve in some of the inhalers. Recipients of these batches are requested to quarantine any remaining stock and to return it via their suppliers. Further information can be obtained from 3M Health Care (tel 01509 613028).

ALERT: Cytarabine injection (19 September)

Vials from the following batches of Cytarabine 100mg/ml solution for injection must be warmed to 55C for a maximum of 30minutes, with adequate shaking, and then allowed to cool to room temperature (Pharmacia):

The advice has been issued as a precautionary measure following reports of crystalline matter (cytarabine) present in vials. Pharmacia has submitted licence variations to include the above requirement for all future batches and also to amend the storage conditions to: Store at 15C to 25C.

Further information can be obtained from medical information, Pharmacia (tel 01908 661101).

RECALL: Dilzem XL 240mg capsules (19 September)

The following batch of Dilzem (diltiazem) XL 240mg capsules is being recalled (Elan UK):

A small number of these capsules have been packaged in blisters intended for Dilzem XL 180mg. Recipients are requested to quarantine all stock of the effected batch and return it to their supplier for credit or replacement. Further information can be obtained from Elan UK's medical information department on 01438 765100.

RECALL: BCG vaccines (13 August)

All batches of the following BCG vaccines have been recalled as a precautionary measure (Evans Vaccines):

• BCG vaccine intradermal
• BCG vaccine percutaneous
• BCG vaccine intradermal isoniazid resistant

During stability testing a number of batches of these products were found not to comply with the requirements of their registered specifications for potency throughout their shelf-lives. Recipients are required to quarantine stock of these products and contact their supplier to arrange for return. Further information can be obtained from the company (tel 08457 451500).

See news item in The Journal

RECALL: Amoxicillin capsules and flucloxacillin capsules (10 August)

The following batches of amoxicillin capsules and flucloxacillin capsules have been recalled as a precautionary measure (Generics [UK]):
Amoxicillin capsules

Flucloxacillin capsules

The above batches have failed to comply with recommendations of the European Pharmacopoeia regarding microbial quanlity. Recipients are required to quarantine stock and return it to their supplier for credit or replacement. Further information can be obtained from Generics (UK), 18 Station Close, Potters Bar, Hertfordshire EN16 1TL (tel 01707 853000).

RECALL: Becotide, Becloforte and Ventide metered dose inhalers recalled (26 July)

Various batches of the following metered dose inhalers with expiry dates in 2004 and 2005 have been recalled as a precautionary measure (GlaxoSmithKline):

• Becotide (beclomethasone dipropionate) 50µg, 100µg and 200µg/inhalation
• Becloforte (beclomethasone dipropionate) 250µg/inhalation
• Ventide (salbutamol 100µg, beclomethasone dipropionate 50µg/inhalation)

Quality control procedures have identified that a small number of inhalers in these batches may have quantities of active ingredients in them which may be above or below specification.

All of the above products are distributed in the livery of GlaxoSmithKline trading as Allen & Hanburys. Becotide and Becloforte metered dose inhalers are also distributed in Boots livery.

Recipients are requested to quarantine stock from these batches and return it to their supplier for credit or replacement. Further information can be obtained from Allen & Hanbury (tel 0800 221 441). GlaxoSmithKline is wrting to doctors and pharmacists with further details of this recall.

RECALL: Adsorbed diphtheria and tetanus vaccine for children (19 July)

The following batch of adsorbed diphtheria and tetanus vaccine (for children) has been recalled as a precautionary measure (Chiron Behring).

Routine stability testing two years after manufacture has shown reduced potency. Any remaining stocks should be quarantined.

RECALL: Mixtard 30 Innolet (13 June)

The following batch of Mixtard 30 Innolet 100iu/ml pre-filled disposable injection devices have been recalled as a precautionary measure (Novo Nordisk).

There is a possibility of under-dosing because of incorrect assembly of some of the devices. Recipients of this batch are requested to quarantine it and to contact their suppliers to arrange for credit or replacement.

Further information can be obtained from Novo Nordisk (tel 01293 613555, fax 01293 613535).

RECALL: Farley's sunrise banana cereal (31 May)

The following batch of Farley's sunrise banana cereal, for infants aged four months and over, has been recalled as a precautionary measure (Heinz):

A small number of packs with this batch number have been incorrectly filled with a different product that contains gluten, wheat and eggs and is suitable for babies from the age of seven months and not four months. Giving this product to sensitive infants may cause an allergic reaction.

Any packs with this batch number should be removed from stock and destroyed. Further information can be obtained by contacting the company's helpline (tel 0800 015 1557).

RECALL: Extraneal peritoneal dialysis solution (29 May)

Batches of Extraneal (icodextrin 7.5 per cent) peritoneal dialysis solution with the following product codes have been recalled (Baxter Healthcare):

The batches have been recalled because of an increased risk of sterile peritonitis. Baxter will be contacting customers directly with further information for pharmacists, clinicians, nurses and patients.

Further details, including individual batch numbers, can be obtained by contacting Baxter renal customer services (tel 01604 704507, fax 01604 704646).

RECALL: ClinOleic and Ivelip emulsions for infusion (23 May)

All batches of the following products have been recalled as a precautionary measure (Baxter healthcare):

The company has received a number of reports from France concerning contamination of surfaces of the closure, notably the stoppers, with Pseudomanas cepacia. There is no evidence to suggest that the contents of the bottles are not sterile.

All batches should be isolated. Baxter says that a letter, with an attached reply form, has been sent to customers. The company will contact those hospitals that reply to arrange for return of stock.

RECALL: Cytosar, Pharmorubicin and doxorubicin (16 May)

The following batches of Cytosar (cytarabine) 1,000mg/10ml injection, Pharmorubicin (epirubicin) 50mg/25ml injection and doxorubicin 50mg/25ml injection have been recalled as a precautionary measure (Pharmacia):

These batches have been recalled because of a lack of sterility assurance during their manufacture. Moulds have been detected during environmental monitoring of the manufacturing facility.

Further information can be obtained from Pharmacia's medical information department (tel 01908 661101) or customer services department (01908 603000).

RECALL: Hydralazine 25mg tablets (18 April)

The following batch of hydralazine 25mg tablets (Alpharma), in the livery of Cox Pharmaceuticals, has been recalled as a precautionary measure:

There have been a small number of reports of discolouration of the tablets. However, there is no evidence that the discolouration is harmful.

Further information can be obtained from Alpharma (tel 01271 311200)

RECALL: Medinol Over 6 oral suspension (27 March)

The following batch of Medinol Over 6 (paracetamol) oral suspension is being recalled by SSL International.

This batch has been recalled due to poor homogeneity of the product. If the bottle is not shaken sufficiently this may lead to variability in the dose administered.

Recipients are requested to quarantine stock of this batch and to return it to their supplier for credit or replacement.

Further information can be obtained from medical information, SSL International, Tubiton House, Oldham OL1 3HS. Tel 0161 652 2222, fax 0161 621 2094.

RECALL: Beclomethasone dipropionate inhalers (27 January)

3M Health Care has recalled the following batches of beclomethasone dipropionate 250µg per metered dose, as a precautionary measure:

Some inhalers from these batches may deliver doses of active ingredient that are marginally lower than specification because of misalignment of the actuator. Recipients are requested to quarantine stock of these batches and to return it to their supplier for credit or replacement.

Further information can be obtained from 3M Health Care, 3M House, Morley Street, Loughborough, Leicestershire LE11 1EP (tel 07885 850673).

RECALL: Phenoxymethylpenicillin 250mg tablets (27 January)

Metwest Pharmaceuticals has recalled the following batch of phenoxymethylpenicillin 250mg tablets.

Some packs may contain patient information leaflets for metformin tablets. Recipients are requested to quarantine stock from this batch and return it to their supplier for credit or replacement.

Further information can be obtained from Metwest Pharmaceuticals, 15 Runnelfield, Harrow-on-the-Hill, Middlesex HA1 3NY (tel 020 7460 4750, fax 020 7460 4050).

DRUG ALERT: Zithromax suspension (17 January 2002)

There is a typographical error on the bottle label of the following batches of Zithromax (azithromycin) 200mg/5ml suspension (Pfizer):

The incorrect label states: "Gently pour medicine into the small end of the spoon (10ml) filling it to the top." The label on the carton is correct and states: "Gently pour medicine into the large end of the spoon (10ml) filling it to the top." Pharmacists holding stock of these batches should ensure that patients are appropriately counselled to use the correct end of the spoon for the dose that they are prescribed.

Further information can be obtained from medical information, Pfizer (tel 01737 331111).