RECALL OF THREE PHARMACEUTICAL PRODUCTS

The Department of Pharmaceutical Services within the Ministry of Health, Wellness, the Environment and Civil Service Affairs advises the public, healthcare providers, pharmacies, wholesalers, distributors and other stakeholders of the recall of three pharmaceutical products known to have been distributed within the State of Antigua and Barbuda.

The recalls affect specific batches/lots of Diovan 160 mg tablets, Atorvastatin 10 mg and 20 mg tablets, and Cetirizine Hydrochloride 5 mg tablets.

Members of the public are urged to check their medication packages against the information provided below and to follow the instructions for returning affected products.

1. RECALL OF DIOVAN 160 MG TABLETS

The U.S. Food and Drug Administration (FDA) announced that Novartis voluntarily initiated a recall of a specific lot of Diovan (valsartan) 160 mg tablets on August 4, 2026.

Diovan contains valsartan, an angiotensin II receptor blocker used to treat conditions including high blood pressure and heart failure.

The recall was initiated due to failed dissolution specifications, meaning that testing identified a quality issue concerning how the medicine dissolves and becomes available for absorption in the body.

The FDA classified the recall as a Class II recall, which generally applies where use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is considered remote.

Affected Product:

Diovan 160 mg Valsartan 160 mg Novartis AV5913C 20 June 2027

Persons who have the affected lot of Diovan 160 mg tablets are advised to:

Do not dispose of the medication in household waste.

Return any unused affected product to the pharmacy where the prescription was filled, or to the wholesaler/distributor from which the product was obtained.

Patients currently taking Diovan should not stop taking their medication without first consulting their doctor or pharmacist, as suddenly stopping medication for blood pressure or heart failure may pose a health risk.

2. RECALL OF ATORVASTATIN 10 MG AND 20 MG TABLETS

The Department of Pharmaceutical Services is also advising of a Category II, Level 2 recall involving specified batches of Atorstan (atorvastatin) 10 mg and 20 mg tablets, manufactured by Remedica.

The affected products remain within their approved shelf life and have been distributed within the jurisdiction.

The recall follows the identification of certain out-of-specification results during ongoing stability testing at the manufacturing facility.

Based on the information currently available, there is no indication of a high risk to patient safety. However, as a precautionary measure and to ensure continued patient safety and compliance with regulatory requirements, a product recall has been initiated.

Affected Products:

Atorstan 10 mg Atorvastatin 10 mg Remedica 129702 17 April 2028

Atorstan 10 mg Atorvastatin 10 mg Remedica 125293 23 July 2027

Atorstan 20 mg Atorvastatin 20 mg Remedica 123164 3 April 2027

Atorstan 20 mg Atorvastatin 20 mg Remedica 128946 18 December 2027

Atorstan 20 mg Atorvastatin 20 mg Remedica 129730 17 April 2028

Patients and customers who have any of the affected batches are advised to return the product to the pharmacy or other place from which it was purchased or obtained.

The deadline for returning the affected Atorvastatin products is September 4, 2026.

Patients who are taking atorvastatin should not discontinue their medication without consulting their doctor or pharmacist. An alternative supply or treatment may be provided where necessary.

3. RECALL OF CETIRIZINE HYDROCHLORIDE 5 MG TABLETS

Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., has initiated a voluntary recall of four lots of Cetirizine Hydrochloride Tablets USP 5 mg due to potential cross-contamination with ranitidine.

The product is an antihistamine used to treat allergic conditions and is packaged in bottles containing 100 tablets.

The issue was identified following a product complaint in which tablets were observed to have red dots and discoloration. The manufacturer subsequently initiated the recall.

Affected Products:

16571-401-10 Cetirizine Hydrochloride 5 mg, 100 tablets Unique Pharmaceutical Laboratories Rising Pharma Holdings Inc. GY825029 10/2028

16571-401-10 Cetirizine Hydrochloride 5 mg, 100 tablets Unique Pharmaceutical Laboratories Rising Pharma Holdings Inc. GY825030 10/2028

16571-401-10 Cetirizine Hydrochloride 5 mg, 100 tablets Unique Pharmaceutical Laboratories Rising Pharma Holdings Inc. GY825031 10/2028

16571-401-10 Cetirizine Hydrochloride 5 mg, 100 tablets Unique Pharmaceutical Laboratories Rising Pharma Holdings Inc. GY825032 10/2028

The manufacturer has advised that, for individuals with a hypersensitivity to ranitidine, exposure to contaminated tablets could potentially result in serious allergic reactions, including anaphylaxis.

To date, the manufacturer has reported no adverse events associated with this recall.

Patients and consumers should:

Check their Cetirizine Hydrochloride 5 mg packaging for the affected lot numbers.

Do not use the product if it belongs to one of the affected lots.

Return the affected product to the pharmacy or place of acquisition.

Contact their physician or healthcare provider if they have experienced any health problems that they believe may be associated with use of the product.

For general or medical inquiries regarding the cetirizine recall, consumers may contact Rising Pharma Holdings Inc. at:

Telephone: 1-844-874-7464

Hours: 8:00 a.m. – 5:00 p.m. EST, Monday–Friday

Email: pv@risingpharma.com or qa@risingpharma.com

The Department of Pharmaceutical Services urges members of the public not to panic but to take the recalls seriously.

Persons who have medication identified in this notice are encouraged to check the product name, strength and lot/batch number carefully and return affected products to the appropriate pharmacy, wholesaler or distributor.

Patients should not stop taking prescribed medication without first speaking with a doctor or pharmacist. Healthcare professionals can advise on whether an alternative supply or treatment is required.

The Department of Pharmaceutical Services encourages all pharmacies, wholesalers, distributors and healthcare providers to immediately review their inventories, identify any affected products and take the necessary steps to remove recalled products from circulation.

The Ministry of Health, Wellness, the Environment and Civil Service Affairs remains committed to safeguarding the health and wellbeing of the people of Antigua and Barbuda and will continue to monitor the situation and provide additional information as necessary.