The nationwide recall of more than 7000 bottles of duloxetine delayed-release capsules is due to unacceptable levels of a potential carcinogen.
The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.
“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website. The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled.
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