The US Food and Drug Administration (FDA) reported the recall of more than 9,000 bottles of fexofenadine, an antihistamine used to relieve symptoms such as sneezing, runny nose, itchy eyes and hives.

The measure affects generic fexofenadine hydrochloride tablets of 180 milligrams, distributed in bottles of 150 units. The recall was initiated after certain batches did not meet established specifications for impurities and drug degradation.

What medication was withdrawn?

The recall includes 9,048 vials of fexofenadine hydrochloride 180 mg manufactured by Sun Pharmaceutical Industries and distributed by New Jersey-based Ohm Laboratories.

Fexofenadine is the active ingredient in medications known commercially as Allegra, although the announced measure does not generally affect all products sold under that brand or all medications that contain this active ingredient. It is limited to the generic lots identified in the report.

The bottles involved contain 150 tablets and correspond to the following lots:

Why was the withdrawal ordered?

The recorded reason is non-compliance with specifications related to impurities or degradation. This means that the medicine did not pass a quality test intended to verify that it retains its characteristics during the useful life period.

The company voluntarily initiated the recall on June 1 and the FDA classified it on June 30. The agency later included the case in its public recall report.

What level of risk does the withdrawal have?

The FDA classified the move as a Class III recall, the lowest risk level within its system.

This category is used when consumption or exposure to the recalled product is not likely to cause adverse health consequences. Class III recalls are typically related to defects in quality, labeling, packaging, or failures to meet certain specifications.

This does not mean that the recall should be ignored, but rather that based on the agency's assessment, the drug is not expected to cause serious harm.

What fexofenadine is used for

Fexofenadine is an antihistamine used to treat allergy symptoms, including:

It works by blocking the effects of histamine, a substance that the body releases during an allergic reaction.

What to do if you have one of the recalled bottles

People taking fexofenadine should check the lot number and expiration date printed on the bottle label. If they match any of the affected lots, the FDA recommends checking with the pharmacy where the drug was obtained or contacting a healthcare professional.

As a Class III recall, patients can generally continue taking the medication unless otherwise directed by the manufacturer, pharmacist, or doctor. Stopping a treatment without professional guidance can be more harmful than continuing to use it temporarily.

The FDA also advises retaining the container, as the pharmacy may request it to verify the lot and explain the return or replacement procedure.

This news has been tken from authentic news syndicates and agencies and only the wordings has been changed keeping the menaing intact. We have not done personal research yet and do not guarantee the complete genuinity and request you to verify from other sources too.