Class 2 medicines recall: Respontin Nebules 250micrograms/1ml & Respontin Nebules 500micrograms/2ml (Ipratropium Bromide)
Action within 48 hours: Glaxo Wellcome UK Ltd is recalling 4 batches of Respontin Nebules due to out of specification results for impurities obtained during routine stability testing (EL (16)A/10)
Product information
EL number
EL (16)A/10
MDR number
MDR 23-08/16
Company name
Glaxo Wellcome UK Limited
Product description
| Batch Number | Expiry Date | Pack Size | First distributed |
|---|---|---|---|
| B76315BA | 28/02/2017 | 20 x 1ml | 30 Mar 2015 |
| B85515J | 31/10/2017 | 20 x 1ml | 27 Jan 2016 |
| B76315BA | 28/02/2017 | 4 x 5 x 2ml | 29 May 2015 |
| B85515J | 31/10/2017 | 4 x 5 x 2ml | 18 Dec 2015 |
Brief description of the problem
GlaxoSmithKline on behalf of the licence holder, Glaxo Wellcome UK Limited, is recalling the above batches because out of specification results for impurities were obtained during routine stability testing. No complaints or adverse reactions relating to this issue have been received by the company to date.
Remaining stocks of these batches should be quarantined and returned to the original supplier for credit. Please note, these products are being discontinued so no alternative batches are available however we understand that alternative versions of both presentations are available from a number of suppliers.
For returns and credit enquiries, please contact your local branch of AAH or Alliance Healthcare.
For medical information enquiries, please contact GlaxoSmithKline UK Medical Information Department on 0800 221 441 and choose Option 2
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Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams: please cascade to relevant clinics, general practitioners and community pharmacies.