Class 2 MHRA Medicines Recall: Zantac preparations – POM only (GlaxoSmithKline)

Class 2 MHRA Medicines Recall: Zantac preparations – POM only (GlaxoSmithKline)

October 8, 2019

Drug alert number: EL (19)A/24

Date of issue: 08 October 2019

MHRA Ref: MDR 56-09/19

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 pharmacy level medicines recall, to be actioned within 48 hours for the following:

Product  PL Number
Zantac Syrup 150mg/10ml 10949/0108
Zantac Injection 50mg/2ml 10949/0109
Zantac Tablets 150mg 10949/0042
Zantac Tablets 300mg 10949/0043

GlaxoSmithKline is recalling all unexpired stock of the above products from pharmacies as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Please quarantine all remaining stock of the above batch and return it to your supplier using your supplier’s approved process.

To view the alert please visit the GOV.UK website.

Company contacts for further information

For stock control enquiries please refer to https://gskpro.com/en-gb/ or contact 0800-221-441.

For medical information enquiries please contact ukmedinfo@gsk.com, via the Live Chat facility on https://hcp.gsk.co.uk/contact-us/live-chat.html or on 0800 221 441 (option 2).



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