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Sleep Disorder Drug Recall Expanded

Feb 9, 2005 | AP

A pharmaceutical company is expanding a nationwide recall from last month to cover all lots of a drug used to treat attention deficit hyperactivity disorder and narcolepsy.

The Methylin Chewable Tablets may contain wrong amounts of its active ingredient, which could pose health risks to some patients, Alliant Pharmaceuticals Inc. said Wednesday.

The Alpharetta, Ga.based company voluntarily recalled a single lot of its 5-milligram strength tablets on Jan. 14, saying they may contain as much as three times the active ingredient.

Further investigation by the manufacturer, Mallinckrodt Inc. of St. Louis, found that tablets of all dosage strengths may have too much or too little methylphenidate.

The drug's maker blamed the potential problem on a "mixing issue" but said nothing is wrong with the active ingredient.

Alliant chief executive Mark Pugh said no other problems have been discovered beyond the initially recalled 5-milligram lot, but that the company decided to expand the recall as a precaution. No one has reported adverse effects from taking the drug, he said.

The recalled medication came in 100-tablet bottles of the following lot numbers:

2.5-milligram dosage: AMT20401A, AMT20402A, AMT20403A, AMT20404A.

5-milligram dosage: AMT50401A, AMT50402A (previously recalled), AMT50403A, AMT50404A.

10-milligram dosage: AMT100401A, AMT100402A, AMT100403A, AMT100404A.

Pugh said fewer than 5,000 bottles of approximately 10,000 manufactured have been distributed.

Alliant Pharmaceuticals, which is cooperating with the Food and Drug Administration (news - web sites) on the recall, said it is sending letters to wholesalers and pharmacists. The company is urging distributors and pharmacies to quarantine any medicine that matches the lot numbers, and is asking pharmacists to notify patients who received the prescriptions.

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