17 May 2012
Class 3 Medicines Recall – Action within 5 days – Pharmacy level recall
Fulsovin (Griseofulvin) oral suspension 125mg/5ml
(manufactured by Kappin)
PL 20249/0009
All remaining stock of the above product is being recalled because stability tests have shown that the product does not comply with the required specifications for the duration of the shelf life.
All remaining stock should be quarantined and returned to the original supplier for credit.
No further batches of Fulsovin (Griseofulvin) oral suspension 125mg/5ml will be released until the issue has been resolved.
There is no direct alternative for some paediatric indications and if a prescription is received there is an unlicensed product available. Pharmacists should, however, seek assurances that the product they supply incorporates a Griseofulvin drug substance that is in full compliance with the requirements of the Ph.Eur/BP monograph including the particle size distribution described in the monograph.
For medical information, contact Kappin on 020 89618511 or email orbispv@orbiscpl.com.
