Concordia International (formerly AMCo) is recalling a batch of Hydrocortisone 100mg/1ml Solution for Injection (Hydrocortisone Sodium Phosphate ) as a precaution following the receipt of a number of complaints that the solution in some ampoules has a yellowish appearance.

Investigation of affected samples has shown that all other analytical parameters, including assay and related substances, are met. A toxicological evaluation carried out by the company concluded that the discoloured ampoules pose no risk to patients. Some packs may contain one or more discoloured ampoules, however, and it is possible that the variance in colour may give rise to concern.

Remaining stock of this batch should be quarantined and returned to the original supplier for credit within five days.

Visit the MHRA website for the full alert.