Urgent Medicine Recall Notice. Are You Affected? Read This!

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
Figure 1: Printed side of the blister pack; click image for a larger and clearer version.

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.

CONTACT DETAILS
  • 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 my.corporatecommunications@gsk.com
  • 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 / csc@zuelligpharma.com
  • Any matter related to Human Safety Information / Adverse Event, please contact GSK Pharmacovigilance at drugsafetyinfo.my@gsk.com

Read All About It: Drug Control Authority Recalls a Cough Medicine!

WORDS LIM TECK CHOON

FEATURED EXPERT
LIM EN NI
Chief Pharmacist
Alpro Pharmacy

Recently, the Drug Control Authority under the Ministry of Health Malaysia issued a circular on the cancellation and product recall of pholcodine, an opioid medicine that is used in adults and children for the treatment of non-productive or dry cough. It is also used in combination with other active substances for the treatment of symptoms of cold and flu.

In Malaysia, you’ll need a doctor’s prescription to obtain pholcodine.

You can read more about the recall at the National Pharmaceutical Regulatory Agency website here (link opens at a new tab).

According to Lim En Ni, this recall is due to a possible drug interaction with neuromuscular blocking agents.

WAIT, WHAT ARE NEUROMUSCULAR BLOCKING AGENTS?

These are medications that are commonly used for general anaesthesia during medical surgeries.

There are a few types of neuromuscular blocking agents, but generally, they prevent normal transfer of information through nerves at your neuromuscular junction.

This keeps you from moving the skeletal muscles connected to the affected neuromuscular junction, hence the use of these medications as anaesthesia.

SO, WHAT DOES PHOLCODINE HAVE ANYTHING TO DO WITH THESE AGENTS?

Lim En Ni explains that people that take pholcodine-containing products in the past 12 months are at risk of experiencing anaphylaxis should they also receive neuromuscular blocking agents.

“Anaphylaxis is a serious, life-threatening allergic reaction,” she says.

ANAPHYLAXIS IS A SERIOUS MATTER
  • It can occur within seconds or minutes of exposure to something you’re allergic to.
  • When you experience anaphylaxis, your immune system will release chemicals that can cause your blood pressure to experience a sudden drop. Also, your airways to block and you will experience problems breathing normally. You will also typically experience weak blood pulse, skin rashes, nausea, and vomiting.
  • You will need an injection of epinephrine to stabilize your condition and then immediately proceed to an emergency room for quick treatment. Delays in getting treatment can lead to death!

WHAT YOU CAN DO ABOUT THIS MATTER

En Ni advises the following:

  • If you have purchased the medication but have not consumed it, you can return it to the pharmacy or healthcare facility that you obtained the medication from.
  • If you have used pholcodine in the last 12 months, visit a pharmacy and ask the pharmacist to help you prepare a medication list to show your surgeon or doctor should you need to undergo surgery. 
  • If you’re not sure whether you have taken pholcodine or your medicine contains pholcodine, consult a pharmacist for help.