Medicine recalls
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| The United Kingdom: Class 3 medicines recall (Action within 5 days): Hydrocortisone 100mg/1ml Solution for Injection - solution in some ampoules has a yellowish appearance |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Concordia International (formerly AMCo) is recalling Hydrocortisone 100mg/1ml Solution for Injection containing Hydrocortisone Sodium Phosphate (batch no.: 039268). The marketing authorisation holder of the product is Amdipharm UK Limited.
This is 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/hydrocortisone-100mg-1ml-solution-for-injection-solution-in-some-ampoules-has-a-yellowish-appearance
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Wednesday, November 09, 2016
Issued at HKT 15:00
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