Three Pharmaceutical – The Department of Pharmaceutical Services has recalled specific batches of three pharmaceutical products distributed in Antigua and Barbuda.
Three Pharmaceutical Products Recalled
The recall affects Diovan 160 mg tablets, Atorstan (atorvastatin) 10 mg and 20 mg tablets, and Cetirizine Hydrochloride 5 mg tablets.
A press release from the Ministry of Health said members of the public are being urged to check their medication packaging for the affected lot or batch numbers and return recalled products to the pharmacy, wholesaler, distributor or other place from which they were obtained. People with the affected lot should not dispose of the medication in household waste.
Patients taking Diovan or atorvastatin should not stop their medication without first consulting a doctor or pharmacist, as an alternative supply or treatment may be necessary, the ministry said.
Novartis voluntarily recalled lot AV5913C of Diovan 160 mg tablets, with an expiry date of 20 June 2027, after the product failed dissolution specifications.
Diovan contains valsartan and is used to treat conditions including high blood pressure and heart failure.
The recall is classified as Class II, which generally applies where exposure may cause temporary or medically reversible health consequences, or where the likelihood of serious consequences is considered remote.
The Department is also recalling five specified batches of Atorstan atorvastatin tablets manufactured by Remedica.
The affected batches are 10 mg-129702, expiry April 17, 2028, and 125293, expiry July 23, 2027. The 20 mg batches are 123164, expiry April 3, 2027; 128946, expiry December 18, 2027 and 129730, expiry April 17, 2028
The recall follows out-of-specification results identified during stability testing at the manufacturing facility.
The Ministry of Health said there is currently no indication of a high risk to patient safety, but the recall was initiated as a precaution.
Affected atorvastatin products should be returned by September 4, 2026 to the pharmacy or other place where they were purchased or obtained.
Four lots of Cetirizine Hydrochloride 5 mg tablets are also being recalled because of potential cross-contamination with ranitidine.
The affected lots are GY825029, GY825030, GY825031 and GY825032, all with an expiry date of October 2028.
The antihistamine is packaged in bottles containing 100 tablets. The issue was identified after a complaint involving red dots and discolouration on tablets.
People with a hypersensitivity to ranitidine could potentially suffer serious allergic reactions, including anaphylaxis, if exposed to contaminated tablets. No adverse events have been reported to date.
Anyone who experiences health problems believed to be associated with the product should contact a doctor or healthcare provider.
The ministry is also asking pharmacies, wholesalers, distributors and healthcare providers to check their inventories, identify affected products and remove them from circulation.
The public is being urged not to panic but to take the recalls seriously by checking medication names, strengths and lot or batch numbers carefully.
