Hydrocortisone 100mg/1ml Solution for Injection - solution in some ampoules has a yellowish appearance

(Amdipharm UK Limited) Remaining stock of this batch should be quarantined and returned to the original supplier for credit - class 3 action within 5 days (EL (16)A/15)

Product information

EL number

EL (16)A/15

MDR number

MDR 23-10/16

Company name

Amdipharm UK Limited

Product description

Hydrocortisone 100mg/1ml Solution for Injection (Hydrocortisone Sodium Phosphate )

PL 20072/0229

Batch number/expiry

Batch no Expiry date Pack sizee First distributed
039268 Aug 2017 1 x 5 27 May 2016

Brief description of the problem

Concordia International (formerly AMCo) is recalling the above batch 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.

Company details

For stock enquiries please contact Concordia Customer Care Services on 08708 877025 or customercare@concordiarx.com

For medical information enquiries please contact Concordia Medical Information on 08700 703033 or medicalinformation@concordiarx.com

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Hydrocortisone 100mg/1ml Solution for Injection EL (16)A/15

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional teams: please cascade to relevant clinics, general practitioners and community pharmacists.

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