Anti-depression drug recalled. A labeling error might cause dangerous levels of sedation
One lot of clinical depression treatment Mirtazapine has been recalled because the tablets in the bottle might be twice as strong as the bottle’s label indicates.
Aurobindo’s FDA-posted recall notice says the labels on lot No. 03119002A3, expiration 03/2022, say the 500-count bottles should have 7.5 mg tablets of the medicine also sold under the brand name Remeron. Problem is, the bottles might have 15 mg tablets.
“Taking a higher dose than expected may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more,” the notice states.
“Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.”
Consumers with questions about the recall or needing to report a bad reaction from the pills being too strong can contact Aurobindo by phone (866-850-2876, option No. 2) or email (pvg@aurobindousa.com). In the case of a bad reaction, contact a health care provider first.
To return the tablets, contact Qualanex by email at mecall@qualanex.com or by phone at 888-504-2014. You’ll get a live person Monday through Friday, 8 a.m. to 5 p.m., Eastern time.
This story was originally published January 2, 2020 at 11:36 AM with the headline "Anti-depression drug recalled. A labeling error might cause dangerous levels of sedation."
