Erythromycin Oral Suspension – manufacturers certificate withdrawn

(Pinewood Laboratories Limited) Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit – class 2 action within 48 hours. (EL (13)A/18)

11 July 2013

Class 2 medicines recall

Action within 48 hours

Pharmacy, wholesaler and clinic-level recall

MDR 46-04/13

Product details

Pinewood Laboratories Limited

Erythromycin 125mg/5ml sugar free granules for oral suspension   PL 04917/0048
Erythromycin 250mg/5ml sugar free granules for oral suspension   PL 04917/0049
Erythromycin 500mg/5ml sugar free granules for oral suspension   PL 04917/0050

Alert details

Product   Batch number   Expiry date   First distributed
Erythromycin 500mg/5ml sugar free   DM11748   June 2015   8 May 2013
Erythromycin 250mg/5ml sugar free   DM12089   July 2015   31 May 2013
Erythromycin 125mg/5ml sugar free   DL12462   September 2014   21 June 2013

All remaining stock of the above batches is being recalled as a precautionary measure following a routine inspection of the contract manufacturing site in India.  The inspection identified deficiencies in good manufacturing practice (GMP) and the GMP certificate for this site has been withdrawn.

These products have been tested on importation and Qualified Person (QP) released. There is no evidence of a risk to patient safety from products currently in the UK market; however it is considered that the products have not been manufactured in line with GMP requirements.

We do not anticipate that supplies of erythromycin oral suspension will be affected by this recall; the company has confirmed that stocks from an alternative manufacturing site are available.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Pinewood Laboratories Ltd Customer services on 00353 52 6186000 or email international@pinewood.ie.

For medical information enquiries please contact Wockhardt UK Ltd Medical Information on 01978 661261 or email drug.safety@wockhardt.co.uk.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

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