US allergy medicine recall: FDA warns of severe reactions linked to possible ranitidine contamination

A nationwide recall has been issued for four lots of cetirizine hydrochloride 5 mg tablets, a generic antihistamine commonly used to treat seasonal allergies, after a potential cross-contamination with ranitidine, a heartburn medication, was identified, according to the US Food and Drug Administration (FDA).

FDA recalls allergy tablets over possible ranitidine contamination

Unique Pharmaceutical Laboratories, a division of JB Chemicals & Pharmaceuticals Ltd., announced the voluntary recall on 18 July. The FDA published the recall notice on 20 July, stating that the affected tablets were distributed across the US by Rising Pharma Holdings Inc. The medicines were sold in 100-tablet high-density polyethylene bottles under the Rising Pharma Holdings name.

The recall was initiated after a pharmacy technician noticed a red dot on some tablets while counting and bottling them for dispensing. Other tablets were found to be discoloured, prompting a product complaint and further concern about a possible quality issue.

The FDA said the affected medicine is cetirizine hydrochloride tablets USP 5 mg, a generic version of the active ingredient used in allergy medicines such as Zyrtec. The agency said the tablets may have been cross-contaminated with ranitidine.

Why is this cross-contamination so concerning?

The potential contamination is particularly concerning for consumers who are hypersensitive to ingredients contained in ranitidine. According to the FDA, exposure could result in serious adverse events, including severe hypersensitivity reactions and anaphylaxis.

Possible symptoms listed by the agency include hypotension, shortness of breath, difficulty swallowing, throat and facial swelling, generalised itching, hives and loss of consciousness.

The FDA said such reactions can be life-threatening. However, no adverse events associated with the recall had been reported to Unique Pharmaceutical Laboratories as of the announcement.

The affected products can be identified by the product name, manufacturer information and lot number printed on the bottle. All four recalled lots have an expiry date of October 2028 and carry the same National Drug Code (NDC), 16571-401-10.

The recalled lot numbers are:

GY825029

GY825030

GY825031

GY825032

The tablets were manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc. to wholesalers and retailers nationwide. Rising Pharma has notified its customers and is arranging for the return of all recalled products.

The FDA's recall notice said the issue was identified through a complaint involving the appearance of red dots on the cetirizine tablets. The company said some tablets appeared discoloured because of multiple red-coloured dots.

Consumers who have the affected product have been advised to check the lot number on the bottle and avoid using tablets from the recalled lots until they have received guidance from a healthcare professional or the product has been returned through the recall process.

The recall is being conducted with the knowledge of the FDA. The agency also said adverse reactions or quality problems linked to the product can be reported through its MedWatch programme.

What is Rantidine?

Ranitidine, historically used to treat heartburn and other acid-related conditions, has previously been the subject of significant regulatory scrutiny in the US.

The FDA had earlier raised concerns about the possible presence of the impurity N-nitrosodimethylamine, or NDMA, in ranitidine products, although the current cetirizine recall is specifically related to the potential for cross-contamination with ranitidine and the risk of hypersensitivity reactions.