Pfizer’s Greenstone Recalls Super/Sub Potent Drugs

Pfizer subsidiary Greenstone has recalled multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential to be super potent or sub potent. They were distributed nationwide to wholesalers/retailers from 11/2016 through 6/2017. “The use of this product in patients with uncontrolled diarrhea due to chronic medical conditions may predispose the patient to toxicity from either the diphenoxylate or atropine components,” a MedWatch notice says. “The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable. If a patient was to receive a sub potent tablet, symptoms may not be controlled. To date, there have been no reports of adverse events related to this recall.”