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 riskFeb 9, 2005 | www.fda.gov
Alliant Pharmaceuticals, Inc. is expanding its voluntary recall of MethylinÂ® (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.
MethylinÂ® (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