MHRA publishes a class 2 Medicines recall for Sodium Cromoglicate eye drops

The Medicines and Health products Regulation Agency (MHRA) published a medical drug alert on the 18^th May 2017 issuing a precautionary recall for bottles of eye drops amidst concerns that the solution can solidify in its container.

Sodium Cromoglicate solution eye drops are typically used to treat red, watery and itchy eyes. Common users are allergy suffers who react adversely to animal hairs, dust or pollen. Marketed as anti-inflammatory, it’s a remedy to alleviate itching and prevent damage to the eyes and delicate surrounding skin by rubbing. The eye drops are also used by contact lens wearers too.

Side effects from eye drops

Side effects can include mild irritation to the eyes in the form of burning and stinging as well as blurred vision from adjusting to the drops. Eyes are extremely delicate and therefore anything that touches our eyes must be gentle enough not to cause too much irritation.

Eye drops must therefore be sterile and free from contamination. Users are normally instructed to keep the bottles for a specific amount of time and to keep them in a cool dry place, away for too much heat or light as this can cause an adverse reaction in the chemicals that make up the eye drop solution.

A common effect is crystallisation. This is also commonly seen in liquid medication that has been kept open for too long. However, FDC International Ltd manufactured Sodium Cromoglicate 2% w/v 13.5ml eye drops have been observed to precipitate even in unopened bottles. The solidification of the eye drops can potentially be dangerous.

The following batch numbers have thus been recalled by the manufacturer:

Both batches were reportedly first distributed on 21^st September 2016 and have an expiry date of June 2018.

Batches to be quarantined

Suppliers and distributors are requested to quarantine any of the affected batches they have in stock and return them to the manufacturer: FDC International Ltd. The NHS has been informed of the recall and are expected to forward the information to their pharmacies, clinics and GPs who provide medication for patients. The Class 2 Medicines Recall alleviates the medical recall to be actioned within 48 hours.