Hydrocortisone 100mg/1ml Solution for Injection - solution in some ampoules has a yellowish appearance
- Medicines and Healthcare products Regulatory Agency
- 8 November 2016
- 8 November 2016
- Alert type:
- Drug alert
(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)
Amdipharm UK Limited
Hydrocortisone 100mg/1ml Solution for Injection (Hydrocortisone Sodium Phosphate )
|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.
For stock enquiries please contact Concordia Customer Care Services on 08708 877025 or firstname.lastname@example.org
For medical information enquiries please contact Concordia Medical Information on 08700 703033 or email@example.com
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.
Published: 8 November 2016
Issued: 8 November 2016
Alert type: Drug alert