Recall of Two Batches of Romesec 20mg Capsules Due to Quality Defect

The Health Sciences Authority (HSA) is overseeing the recall of two batches of Romesec 20mg capsules by Ranbaxy (Malaysia) Sdn. Bhd. This is due to the detection of a faster than expected degradation of the active ingredient, omeprazole, over its 3-year shelf life.

HSA's Advisory

2 The quicker than expected decrease in the amount of omeprazole may make the medicine less effective for the medical conditions being treated. Romesec 20mg is used to treat gastrointestinal conditions where there is too much gastric juice produced, including indigestion, acid reflux, stomach ulcers and Helicobacter pylori infections¹.

3 The two affected batches are listed in Table A. They have been distributed to 26 private clinics and the Mustafa retail pharmacy from October 2018 to June 2019, as listed in Annex A (pdf version). Public healthcare institutions are not affected.

Table A: List of recalled batches of Romesec 20mg capsule

Batch Number	Expiry
3963179	30 April 2021
19010069	31 July 2021

Please refer to Annex B (pdf version) for pictures of the medicine, its packaging and where to find the batch number and expiry date.

Background

4 To ensure that local medicines adhere to HSA’s regulatory requirements for safety, quality and efficacy, manufacturers are required to conduct regular quality tests on their medicines. The quality defect in the two batches of Romesec Capsule 20mg was detected during a recent routine testing by Ranbaxy (Malaysia). The amount of omeprazole in the affected batches of Romesec was found to be below 20mg, at least 20% lower than what it should have been. Investigations found that the likely cause was improper sealing of the capsule, which resulted in moisture within the capsule that degraded the omeprazole.

5 HSA is working with the company to implement the necessary measures to address the issue.

Consumer advisory

6 The recall is conducted as a precautionary measure as both batches of Romesec 20mg capsules may be less effective for the conditions being treated due to the decrease in active ingredient.

7 Patients taking the affected batches of Romesec 20mg capsules are advised to::

1. Continue taking your medicines until you have consulted your healthcare professional. For medical conditions such as stomach ulcer and Helicobacter pylori infection, untreated stomach conditions may lead to a worsening of the medical conditions;
2. Return to the clinic or pharmacy where you obtained your medicine, at your earliest convenience. Discuss your treatment options with your doctor or pharmacist. Depending on your medical condition and whether further treatment is required, your doctor or pharmacist may provide you with a different brand of omeprazole, or an alternative medicine.

For further enquiries, members of the public may wish to contact Ranbaxy (Malaysia) at 6694 0750 from 9am to 5pm (Monday – Friday).

HEALTH SCIENCES AUTHORITY
SINGAPORE
15 AUGUST 2019

¹Helicobacter pylori is a bacterium that can infect the stomach. The bacteria have been associated with the formation of stomach ulcers. Treatment of Helicobacter pylori may involve a combination of medicines including omeprazole with antibiotics.

Download pdf version here676 KB

Published: 15 Aug 2019

HSA Updates