Erythromycin Oral Suspension – manufacturers certificate withdrawn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inspection identified deficiencies in good manufacturing practice (GMP) and the GMP certificate for this site has been withdrawn.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.