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An Upsurge in Recalls of Overweight Tablets and a Recent FDA Warning Letter Show Industry’s Process Understanding Shortcomings

Mar 5th, 2012

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A marked upswing in recalls of overweight tablets during the past few years and a recent warning letter from FDA point to a lack of understanding by pharma manufacturers of their processes and the many variables that can contribute to producing overweight tablets and not detecting them prior to shipping.

The agency gave voice to its concern with this lack of understanding in an early February warning letter to Eatontown, New Jersey-based West-Ward Pharmaceuticals.

Given the number of recent recalls involving tablet weight problems across the industry, a warning letter focused on the related issues was overdue from FDA and more agency compliance attention on the issue would appear likely.

The West-Ward warning letter, which resulted from multi-week inspections conducted in February 2010 and June 2011, called into question the firm’s tablet operations and procedures that permitted the manufacture and release of digoxin and lithium carbonate tablets that failed size and hardness specifications.

On the heels of the 2010 inspection West-Ward initiated a Class I-rated recall of four million tablets of digoxin.  According to the FDA listing, the recall of the narrow therapeutic range drug stemmed from a pharmacist’s report of tablet thickness variation in 1000-count bottles.

[The story, which continues for subscribers beginning on page 2, includes an incisive analysis by a key industry expert of the upsurge in overweight tablet recalls over the past few years and the contributing factors.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

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