Recalled products (2001)

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9 May 2001

Alupent syrup ...[more]

10 October 2001

Amoxicillin capsules ...[more]

2 March 2001

Beclometasone dipropionate ...[more]

24 July 2001

Bonefos capsules ...[more]

3 April 2001

Calcitriol capsules ...[more]

10 October 2001

Cefotaxime injection ...[more]

19 September 2001

Dental cartidges (Deproco Ltd) 2.2ml ... [more]

4 October 2001

Dermestril-Septem patches ...[more]

22 February 2001

Elleste-Duet 2mg tablets ...[more]

20 March 2001
29 January 2001

Epaderm ointment 500g ...[more]

10 April 2001

Glyceryl trinitrate 500µg tablets... [more]

22 August 2001

Hydralazine 25 tablets... [more]

18 October 2001

Isoket infusion ... [more]

1 November 2001

Kefadim injection ... [more]

14 May 2001

MST Continus suspension... [more]

28 November 2001

Omnic capsules ...[more]

27 June 2001

Oxybutynin hydrochloride 2.5mg tablets ...[more]

17 August 2001

SMA infant milk formula powders ...[more]

20 September 2001

Seranace injection ...[more]

31 October 2001

Seretide 50 Evohaler ...[more]

8 March 2001

Valium ampoules ...[more]

22 November 2001

Vaqta Paediatric and Adolescent vaccine ...[more]

8 December 2001

Vaqta Vaccine ...[more]

PRODUCT ALERTS

17 August 2001

Imodium and Arret tamper seals ...[more]

21 December 2001

Kava-kava (consider removing products)...[more]

DRUG ALERTS

19 December 2001

Sandoglobulin 1g Normal Immunoglobulin for intravenous use ...[more]

PRODUCT ALERT: Consider removing Kava-kava products (21 December)

Pharmacists may wish to consider temporarily withdrawing products containing Kava-kava, the Royal Pharmaceutical Society says, following reported links between the herbal product and cases of hepatotoxicity.

Regulatory authorities in Germany and Switzerland have linked Kava-kava products with 30 cases of severe hepatoxicity over the past two years. The Medicines Control Agency held a meeting for interested parties on 19 December. As a result manufacturers in the United Kingdom have agreed to stop supplying the product temporarily.

Boots The Chemists and Lloydspharmacy have removed products from shelves in their stores.

Potter's Herbal Medicines have temporarily suspended the supply of Antiglan tablets, GB tablets and Protat Liquid, all of which contain small amounts of Kava-kava.

Further information is available on the Royal Pharmaceutical Society's website (Society members only).

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DRUG ALERT: Sandoglobulin 1g Normal Immunoglobulin for intravenous use (19 December)

The diluent (0.9 per cent sodium chloride for injection, 33ml) provided with Sandoglobulin 1g Normal Immunoglobulin for intravenous use (Novartis Pharmaceuticals) has been found, in a number of batches, to have developed a precipitate in the fourth and fifth years of its shelf-life. The following safety reminder has been issued by Novartis Pharmaceuticals:

Users are reminded that they must follow the instructions for use provided with Sandoglobulin. In particular:

• Check the vials for any particles or precipitate
• Any vials with visible particles or precipitate must not be used
• Sandoglobulin must only be administered with the 15micron in-line filter provided in place

Questions shoule be directed to medical information, Novartis Pharmaceuticals, Wimblehurst Road, Horsham, West Sussex RH12 5AB (tel 01276 698370, fax 01276 698449).

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Vaqta vaccines (8 December)

Further to the recent recall of Vaqta Paediatric and Adolescent vaccine (formaldehyde-inactivated hepatitis A virus) in 0.5ml prefilled syringes, batch number HN55760 (PJ, 24 November, p743), Aventis Pasteur MSD is recalling all remaining batches (see below) of the product as a precautionary measure. The company is also recalling all batches of Vaqta Adult vaccine in 1ml prefilled syringes.

The Department of Health says that patients who have received either vaccine since their launch may not have adequate and continuing protection against infection. The Department recommends that individuals at continuing risk of hepatitis A who have been immunised with Vaqta products only, should start their immunisation schedule again with another hepatitis A vaccine product. Those who have been immunised in anticipation of travelling to areas of increased endemicity for hepatitis A in the near future should be re-immunised immediately. It also recommends that those who have received both a Vaqta product and another hepatitis A product as part of their immunisation, should, for continuing protection, receive a further dose of another hepatitis A product.

Recipients are requested to quarantine stocks and contact their supplier to arrange for return. If stock was supplied direct from Aventis Pasteur MSD, the company will be in contact to arrange for return of unused doses. For medical enquiries, the company's vaccine information service can be contacted on 0800 587 2390).

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Omnic capsules recalled (28 November)

G-Pharma Ltd has recalled its parallel import product Omnic (tamosulosin hydrochloride) 400µg capsules.

A number of packs re-assembled by G-Pharma under this control number have been found to contain patient information leaflets from another product, Avandia (rosiglitazone) 4mg tablets.

Recipients are requested to quarantine stock and return it to their suppier for credit or replacement.

Further information can be obtained from G-Pharma, Unit 4, Dakota Park, Salford, Greater Manchester M5 2PU (tel 0161 877 8999).

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Vaqta Paediatric and Adolescent vaccine recalled (22 November)

Aventis Pasteur MSD is recalling the following batch of Vaqta Paediatric and Adolescent (formaldehyde-inactivated hepatitis A virus) vaccine in 0.5ml pre-filled syringes:

Recent investigations have found some syringes with potencies below the product specification. Any patient who has received a dose from the batch should receive an additional dose of an appropriate hepatitis A vaccine.

Recipients are requested to quarantine stock and to contact Vaccine Direct, Aventis Pasteur MSD, Mallards Reach, Bridge Avenue, Maidenhead, Berkshire SL6 1QP (tel 0800 0855 511).

Medical inquiries can be directed to Aventis Pasteur MSD's information service on 01628 773737.

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Kefadim injection recall (1 November)

Eli Lilly is recalling of all batches of Kefadim (ceftazidime) 500mg, 1g and 2g injections which are still within their expiry dates and have been distributed from the company's facility at Basingstoke. The recall is being carried out after a review into the level of product sterility assurance. All of these batches met specifications at the time of release.

Recipients are asked to quarantine stock of these batches and return them to Eli Lilly, Kingsclere Road, Basingstoke, Hampshire RG21 6XA. Further information can be obtained from the company's customer care centre (tel 01256 315999).

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Seretide 50 Evohaler recalled (31 October)

GlaxoSmithKline has recalled the following batch of Seretide 50 (salmeterol [as xinafoate] 25µg, fluticasone propionate 50µg) Evohaler, distributed in the livery of Allen & Hanburys:

This batch has not met the end of shelf-life specification agreed with European Union regulatory authorities. GlaxoSmithKline believes that this will not compromise patient safety and does not have any clinical implications. Recipients are asked to quarantine stock and return it to their supplier for credit or replacement. Further information can be obtained from Allen & Hanburys (tel 0800 221 441).

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Isoket infusion (18 October)

Schwarz Pharma is recalling all batches of Isoket (isosorbide dinitrate) infusion 0.1 per cent, pack size 50ml, packed in type II glass bottles, as a precautionary measure. Routine stability testing has found “out of specification” results for some bottles. This recall does not apply to batch number 4392015 as it is packed in type I glass bottles.

Cefotaxime injection recalled (10 October)

Lupin Laboratories is recalling the following batches of cefotaxime injection, distributed by and in the livery of Generics (UK), as a precautionary measure. There have been quality defect reports for two vials from two of these batches:

Recipients are requested to quarantine stock and return it to their supplier for credit or replacement. Further information can be obtained from Generics (UK) on tel 01707 853007.

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Amoxicillin capsules recalled (10 October)

DDSA Pharmaceuticals has recalled the following batch of amoxicillin capsules:

There have been two reports of containers from these batches containing amoxicillin 250mg capsules. Recipients are requested to withdraw stock and return it their supplier for credit or replacement. Further information can be obtained from DDSA Pharmaceuticals (tel 020 7373 7884).

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Dermestril-Septem patches (4 October)

Strakan is recalling the following batches of Dermestril-Septem (estradiol) transdermal patches.

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Serenace injection recalled (20 September)

Norton Healthcare is recalling the following batches of Serenace (haloperidol) ampoules.

The labels, leaflets and cartons of these batches contain unapproved artwork as well as a number of errors and omissions. Recipients are requested to quarantine stock and return it to their supplier for credit or replacement.

Further information can be obtained from Norton Healthcare (tel 020 7540 7651, fax 020 7540 7689).

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Dental cartridges (19 September)

Deproco Ltd is recalling the following products:

The graduations on the labels of these products contain an error. Use of these graduations may result in accidental overdosing. Recipients of these products are requested to quarantine stock and return it to their supplier for credit or replacement.

For further information, contact Deproco on 01622 695520.

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Hydralazine 25mg tablets (22 August)

Alpharma is recalling hydralazine 25mg tablets (packed in Cox Pharmaceuticals livery), as a precationary measure.

The company has received a number of reports of discolouration of tablets from this batch. Recipients are requested to quarantine stock and return it to their supplier for credit or replacement. Further information can be obtained from Alpharma (tel 01271 311203).

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SMA Infant milk formulas (17 August)

SMA Nutrition is recalling the following infant milk formula powders, as a precautionary measure (more details here):

SMA Gold infant milk formula powder

SMA White infant milk formula powder

Pharmacists receiving returns of the above should contact the SMA careline (tel 0800 212002) to make arrangements for returning the product to the supplier and for credit.

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Tamper seals on boxes of Imodium and Arret capsules (17 August)

Johnson & Johnson MSD Consumer Pharmaceuticals is alerting pharmacists to check for faults to tamper seals on boxes of the following loperamide hydrochloride preparations:

Imodium 2mg capsules, pack size=6 01AV765 6 01CV081 6 01EV304 6 01EV242 6 01FV372 6 01FV367 6 01FV378 6 01FV413 6 Arret capsules, pack size =6 01DV204 6 01BV975 6 00JV434 6

Any faulty packs should be returned to the company for credit or replacement. For enquiries contact the company’s customer services department (tel 01494 453670).

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Bonefos capsules (24 July)

Boehringer Ingelheim has recalled Bonefos (sodium clodronate) 400mg capsules.

Batch number 06473

Expiry date November, 2005

Pack size 120

Packs of this batch, meant for the Republic of Ireland, have been mistakenly distributed in the United Kingdom. The patient information leaflet (PIL) in the UK product contains a number of important warnings that are not included in the Irish PIL. This recall applies only to packs of this batch that display the Republic of Ireland product authorisation (PA) number 7/47/1. Packs from the batch with the UK product licence (PL) number 00015/0136 are not affected.

Recipients are requested to quarantine stock and return it to their supplier for credit or replacement. For further information, contact Boehringer Ingelheim (tel 01344 741191).

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Oxybutynin hydrochloride 2.5mg tablets recall (27 June updated)

Generics (UK) has recalled oxybutynin hydrochloride 2.5mg tablets.

Batch number

Expiry date

Pack size

2663X1

February, 2004

84

An incorrect strength (5mg instead of 2.5mg), has been stated on the reverse of the carton. Recipients are requested to quarantine stock and return it direct to Generics (UK), Unit 2 Summit Road, Cranborne Industrial Estate, Potters Bar, Herts EN6 3QW.

Further information can be obtained from Generics (UK) (tel 01707 853000).

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MST Continus suspension (14 May)

Napp Pharmaceuticals is recalling the following batches of MST Continus (morphine sulphate) suspension sachets:

Strength

Batch number

Expiry date

Pack size

20mg

103668

July 15, 2001

30

20mg

102744

September 19, 2001

30

30mg

102177

August 12, 2001

30

30mg

102741

September 1, 2001

30

30mg

103048

September 9, 2001

30

30mg

103047

September 17, 2001

30

100mg

102174

August 12, 2001

30

100mg

103556

August 16, 2001

30

Some of the sachets may have been inadequately sealed during the filling process and fail to comply with the specification for content of active ingredient throughout the shelf-life of the product. 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 Napp Pharmaceuticals (tel 01223 424444).

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Alupent syrup (9 May)

Boehringer Ingelheim has recalled the following batches of Alupent (orciprenaline sulphate) syrup 10mg/5ml:

Batch number

Expiry date

Pack size

031272A

January 31, 2005

300ml

031270B

January 31, 2005

300ml

031271B

January 31, 2005

300ml

031273A

February 28, 2005

300ml

031274A

February 28, 2005

300ml

031275A

February 28, 2005

300ml

031982A

May 31, 2005

300ml

032369A

June 30, 2005

300ml

032370A

August 31, 2005

300ml

032507A

August 31, 2005

300ml

The thread on the aluminium cap in a small proportion of bottles from these batches was poorly formed. In some cases, the cap could not be removed and in others it could not be replaced securely. Recipients are requested to quarantine stock and return it to their supplier for credit or replacement.

Further information can be obtained from Boehringer Ingelheim, customer services (tel 01344 741191).

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Glyceryl trinitrate 500µg tablets (10 April)

Alpharma has recalled the following batches of glyceryl trinitrate 500µg tablets, which are in the livery of Cox Pharmaceuticals:

Batch number

Expiry date

Pack size

GF619

December 2002

100

GF620

February 2003

100

GF621

February 2003

100

Some bottles may be contaminated with glass slivers because of a manufacturing fault with the glass bottles. Recipients are requested to quarantine stock and return it to their supplier for credit or replacement. Further information can be obtained from Alpharma (tel 01271 311355).

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Calcitriol capsules recalled (3 April)

APS/Berk is recalling the following batches of calcitriol

Strength

Batch number

Expiry date

Pack size

0.25µg

559005

April 2002

30

0.50µg

560005

April 2002

30

Stability testing has shown that the batch of active ingredient used to manufacture these two batches has reduced activity.

Recipients are requested to quarantine stock from these batches and return it to APS/Berk for credit and replacement. Further information can be obtained from APS (tel 0800 590502 or 0800 526989).

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Epaderm ointment 500g (20 March)

SSL International has recalled the following batch of Epaderm ointment: Batch number E0700E
Expiry date July, 2002
Pack size 500g

This batch, which should be odourless, has been contaminated with traces of perfume during manufacture. Recipients are requested to quarantine stock and return it to their supplier for credit or replacement.

Further information can be obtained from
SSL International (tel 0161 652 2222).

This recall is in addition to that for two other batches of Epaderm ointment 500g which were recalled earlier this year.

The full list is below

Epaderm ointment 500g recalls

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Valium ampoules recalled (8 March)

Roche Porducts is recalling the following batches of Valium Roche (diazepam) 10mg/2ml ampoules:

This is because during stability testing the company has detected visible particles in samples of over three year old.

Recipients are requested to quarantine stock of these batches and return it to their supplier for credit or replacement. Further information can be obtained from Roche customer services (tel 0800 7315711).

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Beclometasone dipropionate recall (2 March)

3M Health Care is recalling the following batches of beclometasone dipropionate inhalers, in the liveries of 3M Health Care and Generics (UK).

The recall is because the company has discovered that some inhalers from these batches may deliver sporadic low doses of active ingredient. 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 3M Health Care (tel 0585 850673).

Elleste-Duet 2mg tablets recalled (22 February)

Shire Pharmaceutical Contracts is recalling Elleste-Duet 2mg tablets, pack size 3 x 28, batch number 537090, expiry date August, 2003. The product was distributed by Pharmacia and packed in the livery of Searle Division of Monsanto.

Pharmacia has discovered that, because of a packaging error, days 1-12 of the calendar pack contain combination tablets of estradiol 2mg and norethisterone acetate 1mg and days 13-28 contain estradiol 2mg tablets.

Correct calendar packs should contain estradiol 2mg tablets for days 1-16 and combination tablets of estradiol 2mg and norethisterone acetate1mg for days 17-28. Recipients are requested to quarantine stock of this batch and return it to their supplier for credit. Further information can be obtained from Pharmacia (tel 01908 603087).

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Epaderm ointment 500g (29 January)

SSL International is recalling Epaderm (yellow soft paraffin) ointment 500g, batches numbers E0700C and E0700D, expiry date July, 2002. This is because these batches, which should be odourless, have been contaminated with traces of perfume during manufacture. Recipients are requested to quarantine stock of these batches and return it to their supplier for credit or replacement. Further information can be obtained from SSL International (tel 0161 652 2222).

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