The firm, which is a subsidiary of US drugmaker KV Pharmaceuticals, recalled lots numbered 77946, 81141 and 81142 in what it described as a voluntary and precautionary measure.
Unfortunately for Ethex this is not the first occasion that it has been forced to withdraw potentially oversized tablets this year. In June, the company recalled a single batch of its generic version of the painkiller morphine sulphate after similar manufacturing problems.
Commenting on the latest withdrawal, the US Food and Drug Administration (FDA) said that: “Oversized tablets may contain as much as about twice the labelled amount of the active ingredient.”
The agency added that while it has not received reports of unexpected side effects or injury related to dextroamphetamine sulphate, excessive doses of the drug have the potential induce a range of side effects, including tachycardia, hypertension and blurred vision.
The FDA also said that a number of US manufacturers produce generic versions of the withdrawn product, meaning that Ethex’ recall will not significantly impact on supplies.
Ethex is not the only firm to have been hit by multiple manufacturing issues and dosing problems this year. In April, Actavis withdrew all batches of the cardiac drug Digitek (digoxin) after it emerged that they contained twice the intended amount of API.
Prior to that, the FDA asked Caraco, a subsidiary of Sun Pharmaceuticals, to remove several batches of its diabetes treatment metformin from US shelves after it was discovered that some of the tablets did not meet with approved specifications.
Ethex' recall comes at the end of what has been a difficult six month period for the Missouri-headquartered company. In July, FDA officials impounded nearly $24m worth of guaifenesin-containing timed-release (TR) over-the-counter (OTC) cough and cold medicines made by the firm as part of a general clamp down on unapproved uses of the muscle relaxant.