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McNeil Recalls Liquid Infants’ Tylenol With Dosing Device Problem

This article was originally published in The Tan Sheet

Executive Summary

McNeil Consumer Healthcare recalls an Infants’ Tylenol product that returned to market in November, after receiving consumer complaints about a problem with the SimpleMeasure dosing device system. The recall marks a misstep in the J&J subsidiary’s comeback from OTC quality control issues.

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Firm has pending ANDAs for generic versions of McNeil's Rx Concerta (methylphenidare hydrochloride) extended-release tablets in 18, 27, 36 and 54 mg formulations. McNeil's exclusivity for the pediatric hyperactivity deficit disorder drug was set to expire March 17, and the firm has filed a citizen petition with FDA "that affects the timing of, and potentially the approval criteria for, ANDA approvals relating to generic Concerta," according to Andrx. McNeil put 300 sales reps behind the drug in 2000 (1"The Tan Sheet," April 24, 2000, In Brief)...

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