Ministry of Health Recalls Three Medications Over Quality and Contamination Concerns

The Ministry of Health has issued a public notice recalling specific batches of three pharmaceutical products that have been distributed in Antigua and Barbuda, urging patients to check their medication and return any affected products.

The recall, announced through the Department of Pharmaceutical Services, involves Diovan 160 mg tablets, Atorstan 10 mg and 20 mg tablets, and Cetirizine Hydrochloride 5 mg tablets.

Health officials stressed that the recalls apply only to specific batches and advised patients taking prescribed medication not to discontinue treatment without first consulting a doctor or pharmacist.

Diovan 160 mg, which contains valsartan and is used to treat conditions including high blood pressure and heart failure, is being recalled after manufacturer Novartis voluntarily recalled a specific lot following failed dissolution specifications.

The affected batch is AV5913C, with an expiry date of June 20, 2027.

The issue relates to how the medicine dissolves and becomes available for absorption in the body. The recall has been classified by the U.S. Food and Drug Administration as Class II, a category generally used when exposure could result in temporary or medically reversible health consequences or when the likelihood of serious harm is considered remote.

People with the affected Diovan tablets should return any unused medication to the pharmacy where the prescription was filled or to the wholesaler or distributor from which it was obtained. The medication should not be thrown away with household waste.

The Department has also announced a recall of five batches of Atorstan, a brand of atorvastatin manufactured by Remedica.

The affected batches are 129702 and 125293 for Atorstan 10 mg, along with 123164, 128946 and 129730 for Atorstan 20 mg.

The recall follows out-of-specification results identified during ongoing stability testing at the manufacturing facility. Authorities said there is currently no indication of a high risk to patient safety, but the products are being recalled as a precaution.

Customers have until September 4, 2026, to return the affected Atorstan products to the pharmacy or other location where they were purchased or obtained.

Four lots of Cetirizine Hydrochloride 5 mg tablets have also been recalled because of potential cross-contamination with ranitidine.

The affected lot numbers are GY825029, GY825030, GY825031 and GY825032, all with an expiry date of October 2028.

The antihistamine, manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc., is used to treat allergic conditions and is packaged in bottles of 100 tablets.

The potential contamination was discovered after a product complaint involving tablets with red dots and discoloration.

Officials warned that people who are hypersensitive to ranitidine could potentially experience serious allergic reactions, including anaphylaxis, if exposed to contaminated tablets. No adverse events associated with the recall have been reported to date.

Consumers who have cetirizine from any of the affected lots have been advised not to use the tablets and to return them to the pharmacy or other place where they were obtained.

Anyone who believes they have experienced a health problem associated with the affected cetirizine should contact their doctor or healthcare provider.

The Department of Pharmaceutical Services is urging the public not to panic but to take the recalls seriously and carefully check the product name, strength and batch or lot number of their medication.

Pharmacies, wholesalers, distributors and healthcare providers have also been asked to immediately review their inventories and remove affected products from circulation.

The Ministry said it will continue monitoring the recalls and provide further information where necessary.