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Sleep Disorder Agent Methylphenidate HCl Recalled Due to Inaccurate Amounts of Active Ingredient

February 8, 2005 – Alpharetta, Georgia – Alliant Pharmaceuticals, Inc. is expanding its voluntary recall of Methylin (Methylphenidate HCl ) Chewable Tablets to include all lots of the product. The nationwide recall now includes all 2.5 mg, 5 mg and 10 mg dosage strengths because some tablets may contain too much or too little active ingredient.

The company initially elected to recall one lot of 5 mg product, lot #AMT50402A, from the market on January 14, 2005, because it was determined that some tablets may contain up to three times the required amount of active ingredient. After further investigation, the manufacturer, Mallinckrodt, Inc., of St. Louis, MO, determined that there was potential for other lots to contain superpotent and subpotent tablets. Upon Mallinckrodt’s further investigation they found that the potential problem was the result of a manufacturing mixing issue and not due to the medication’s active ingredient.

Methylin (Methylphenidate HCl) Chewable Tablets are a therapy for Attention Deficit Hyperactivity Disorder and Narcolepsy. The drug is sold in 100-tablet bottles and dispensed to patients in amounts prescribed by a physician.

The company notified the FDA of its findings, and is notifying wholesalers and pharmacists of the recall by letter. They are asking pharmacists to attempt to notify patients who were dispensed prescriptions from their pharmacy. Distributors and pharmacies should promptly quarantine any product with the following lot numbers:

- 2.5 mg (NDC 68188-132-01) Lot numbers: AMT20401A, AMT20402A, AMT20403A, AMT20404A

- 5 mg (NDC 68188-135-01) Lot numbers: AMT50401A, AMT50402A (previously recalled), AMT50403A, AMT50404A

- 10 mg (NDC 68188-137-01) Lot numbers: AMT100401A, AMT100402A, AMT100403A, AMT100404A

Alliant’s liquid form of the product – Methylin Oral Solution (5mg / 5mL and 10mg / 5mL strengths) – is not affected by the recall and is still widely available. In addition, Mallinckrodt’s Methylin ER or Methylin immediate release products are not affected by this recall.

Patients should call their pharmacists or physicians if they have questions about the recall. Health care providers or patients who have questions can contact Alliant Pharmaceuticals, at 770-817-4500.

Source: Alliant Pharmaceuticals

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