The voluntary Class III ongoing recall for the extended-release tablets has been initiated as "one lot of product did not meet the first stage dissolution specification limits", USFDA said in the Enforcement Report for the week of October 7, 2015.
The prescription only tablets were in the strength of 240 mg in 500-count bottles, it added.
As per the USFDA a Class III recall is initiated "in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."
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