|THIS IS A PRESS RELEASE FROM GSK MALAYSIA|
Kuala Lumpur, 30 March 2023 – GSK Malaysia is voluntarily recalling one batch of Zyrtec-D (120MG/5MG TABLETS X400), with batch number 321907 and expiry date of January 2025 printed on the blister pack. The recalled product is shown in Figure 1 below.
- The decision to recall the product is a precautionary measure after some units were found to have blisters that were incorrectly sealed.
- At the present time, there is no evidence that any other batches are affected, and no other complaints have been received about this product from any market since 2018.
- Patient safety is of the utmost priority for GSK, and as a responsible pharmaceutical company, we are taking swift action to address the issue.
- This recall does not affect Zyrtec Drop 10mg/ml, Zyrtec Solution 1mg/ml and Zyrtec Tablet 10mg, and patients may continue these medications.
MORE ABOUT THE RECALL
All tablet packs/blisters from this batch are being recalled at all levels in the Malaysian market, including those already dispensed to patients.
- GSK is requesting all patients who have been dispensed Zyrtec-D tablets from any in-country retail, pharmacy, or healthcare outlet to return the product with immediate effect to the original point of purchase, within the next 15 days.
- We urge all healthcare professionals to immediately cease prescribing, dispensing, selling, or distributing product from this batch.
- Patients should seek advice from their healthcare provider on alternative treatments.
We understand that this recall may cause inconvenience to our patients, and we apologize for any inconvenience caused. GSK is committed to supplying high-quality medicines to our patients, and the quality of our products remains our utmost priority. We assure you that we are investigating the matter thoroughly and will take all necessary steps to prevent such incidents from happening in the future.
There is no adverse event reported to GSK Pharmacovigilance for the mentioned batch as of today. GSK monitors and reports safety events for all GSK products and reports to relevant regulatory authorities.
- Consumers or healthcare providers with questions regarding this recall may contact GSK by phone at +603-7495 2600 on Monday through Friday from the hours of 9:00 am to 5:00 pm, or by e-mail at firstname.lastname@example.org
- Patients who have been prescribed and dispensed product from this batch and have concerns should contact their healthcare provider first.
- Pharmacy, clinic and hospital that have recalled product to be returned, please directly contact Zuellig Pharma Sdn Bhd at 1800 88 1388 / email@example.com
- Any matter related to Human Safety Information / Adverse Event, please contact GSK Pharmacovigilance at firstname.lastname@example.org