Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this.
Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'Drug Alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.
Recent Drug Alerts relating to ophthalmology
-
09 Mar 2009 | Class 4 Drug Alert (Caution in use): Merck Sharp and Dohme Limited - Timoptol-LA 0.25% w/v & 0.5% w/v Gel-Forming Eye Drops Solution (Timolol maleate) - EL (09)A07
We have been informed that there is an error in the patient information leaflet (PIL) supplied in certain batches of Timoptol-LA 0.25% w/v and 0.5% w/v Gel-Forming Eye Drops Solution, concerning the dose to be administered.
-
21 Nov 2007 | Class 2 Drug Alert (action within 48 hours): FDC International Ltd, Chloramphenicol eye drops 0.5% in FDC, Almus and Ivax liveries - EL(07)A/26
The MHRA are directing FDC International Ltd to recall any remaining stock of the above products due to rough surfaces on the bottle delivery tip. The product has been distributed in the three liveries listed above.
-
21 Nov 2007 | Class 2 Drug Alert (action within 48 hours): FDC International Ltd - Timolol eye drops 0.25 and 0.5% in FDC, APS, Almus and Ivax liveries - EL(07)A/24
We are directing FDC International Ltd to recall any remaining stock of these products due to rough surfaces on the bottle delivery tip.
