Class 2 medicine recall High risk 18 May 2017

Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops

Yes – this has been recalled
The problem
FDC International Ltd is recalling the batches listed below as a precautionary measure due to a precipitate observed in the bottles.
What to do
Check the batch number on your pack against the list below. Do not stop taking a prescribed medicine without talking to your pharmacist, GP or prescriber first – they can check your supply and swap it if needed.
Source: Medicines and Healthcare products Regulatory Agency (MHRA) Official notice ↗

Product information

PL number

PL15872/0010

MDR number

MDR 072-05/17

Company name

FDC International Ltd.

Product description

Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops

Batch number/expiry

  • Batch number: GJW6071
    • Expiry date: June 2018
    • Pack size: 13.5 mL
    • First distributed: 21 September 2016
  • Batch number: GJW6072
    • Expiry date: June 2018
    • Pack size: 13.5 mL
    • First distributed: 21 September 2016

Brief description of the problem

FDC International Ltd is recalling the batches listed above as a precautionary measure due to a precipitate observed in the bottles. All remaining packs of the listed batches should be quarantined and returned to your supplier.

For stock enquiries, please contact Santosh Amoncar on:

01489 565222

07903 203039

fdcil@btconnect.com

Download document

Sodium Cromoglicate 2% w/v 13.5 mL Eye Drops

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS Regional Teams are asked to forward this to community pharmacists, relevant clinics and dispensing general practitioners. It is not necessary to forward this notice to non-dispensing GPs.

Updated 18 May 2017. This page summarises an official notice. Details can change – always follow the official notice.

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