The affected batch, number 112680A of dosage strength 225mg, was shipped to suppliers between October 15 and November 26 last year having been manufactured by the firm’s Watson Laboratories business unit.
Watson explained that although the variation in active pharmaceutical ingredient (API) content is minor, some patients using the product to treat irregular heat beat may be sensitive to small changes. Such individuals could suffer a range of adverse affects, including cardiac problems and a potential dangerous drop in blood pressure.
The firm said it has notified the US Food and Drug Administration (FDA) of the recall, but reiterated that the recall is a precautionary measure designed to minimize any potential risk to patients and added that it does not foresee any national shortage of the drug as a result of the move.
The recall is not the first for a product manufactured by Watson Laboratories. In August last year the firm was forced to withdraw a batch of its fentanyl transdermal patch product after some were found to leak.
Additionally, by enacting the recall Watson joins the list of drug manufacturers to have pulled batches of products containing oversized tablets from pharmacy shelves in the US.
The most notable of the recent withdrawals was carried KV Pharmaceuticals’ Ethex subsidiary, which recalled specific batches of five generic drugs: propafenone HCl; isosorbride mononitrate ER; morphine sulphate ER; morphine sulphate IR; and dextroamphetamine sulphate, which were all deemed to contain an excessive amount of API.
Prior to the Ethex recalls, generics firms Acavis and Caraco, a subsidiary of Sun Pharmaceuticals, were both forced to withdraw out of spec tablets from US shelves by the country’s drug regulators.