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Chlorthalidone Recall: FDA Class II Recall Affects 13,567 Bottles

A nationwide recall of chlorthalidone blood pressure tablets is now classified as Class II by the FDA after 13,567 bottles of 25 mg tablets failed dissolution testing. The recalled medication was made by Inventia Healthcare Limited and distributed across the United States, including the recalled batch with an April 2027 expiration date.

The Brief

The FDA has classified a chlorthalidone recall as Class II after 13,567 bottles of 25 mg blood pressure tablets failed dissolution testing.
Inventia Healthcare Limited recalled the tablets on Sept. 3, and the recalled batch was distributed nationwide with an expiration date of April 2027.
This is the company’s second chlorthalidone recall this year, following an 11,460-bottle recall in June for the same dissolution testing problem.

What we know:

The FDA classified the chlorthalidone recall as a Class II recall on Sept. 17 after 13,567 bottles of 25 mg tablets failed dissolution testing. Inventia Healthcare Limited began the recall on Sept. 3.

Read More:

The recalled medicine is Chlorthalidone Tablets, USP, 25 mg, from Batch No. RISA24002. The bottles carry an April 2027 expiration date and were distributed nationwide.

Chlorthalidone is a diuretic, also known as a water pill, used to help lower blood pressure. A failed dissolution test means the medicine may not dissolve and be absorbed properly, which could reduce its effectiveness.

This is Inventia Healthcare’s second chlorthalidone recall this year. In June, the company recalled 11,460 bottles of the same medication in 100-tablet and 1,000-tablet sizes for the same dissolution issue.

Recall Activity

Dig deeper:

Inventia Healthcare Limited began the recall on Sept. 3 after 13,567 bottles of 25 mg chlorthalidone tablets failed dissolution testing. The FDA later classified the recall as Class II on Sept. 17.

The recalled tablets were distributed nationwide. This follows another chlorthalidone recall by the same company in June, when 11,460 bottles were recalled for the same dissolution testing issue.

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