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Class 2 Drug Alert (Action within 48 hours): Boehringer Ingelheim Ltd - Oramorph Oral Solution 10mg/5ml

Document details:

Type: Drug Alert
Series No: EL (08)A/17
Audience: Healthcare professionals
Published:
Format: electronic and paper
Size: A4
Pages: 2
Price: Free
ISBN/ISSN: n/a
Author:
Copyright: Crown
   

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DRUG ALERT

Class 2 medicines recall
Action within 48 hours
Pharmacy level recall
26 November 2008 EL (08)A/17 Our ref:  MDR 64-11/08

Dear Healthcare Professional,

Boehringer Ingelheim Ltd

Oramorph Oral Solution

(Each 5ml contains 10mg Morphine Sulphate BP )

PL 00015/0122

Batch Number

Expiry Date

Pack Size

First Distributed

833206A

30/09/2011

100ml

16/10/2008

833207A

30/09/2011

100ml

27/10/2008

833208A

30/09/2011

100ml

05/11/2008

833209A

30/09/2011

100ml

13/11/2008

832873B

31/08/2011

300ml

23/09/2008

833210A

30/09/2011

300ml

20/10/2008

833214A

30/09/2011

500ml

21/10/2008

833215A

30/09/2011

500ml

07/10/2008

833216A

30/09/2011

500ml

28/10/2008

833217A

30/09/2011

500ml

11/11/2008

Boehringer Ingelheim Ltd are recalling all remaining stock of the above batches due to several complaints regarding deviation in taste and some non-serious adverse events.

We understand that this product is used in hospitals and is also supplied via community pharmacies.

All unused stock of the above batches should be quarantined and returned for credit via the original supplier. For returns and credit enquiries, please contact Boehringer Ingelheim Ltd. on 01344 741191.

Medical information can be obtained from the Medical Information Department, Boehringer Ingelheim Ltd via their switchboard, 01344 424600.

Recipients of this Drug Alert should bring this to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of relevant clinics, Community Pharmacists and General Practitioners by copy of this letter.

Yours faithfully

Ian Holloway
MHRA DMRC Manager

MHRA Distribution (further recipients by cascade): Regional Contacts for NHS Trusts and Provider Units
Chief Pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief Pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments
Primary Care Trusts (England)
Page last modified: 26 November 2008