Recall-- Firm
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Alliant Pharmaceuticals Expands Its Voluntary Nationwide Recall of
Methylin® CT, 2.5mg, 5mg, and 10mg tablets
Methylphenidate-based product being voluntarily recalled because of possible health risk
Contact:
Jed Nitzberg
404-881-2319
FOR IMMEDIATE RELEASE -- Alpharetta, Georgia -- February 9, 2005 -- 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 or visit www.alliantpharma.com.
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