The primary outcome was a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery.The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol.Greenstone Issues Voluntary Nationwide Recall of Diphenoxylate Hydrochloride and Atropine Sulfate Tablets, USP Due to Possible Sub Potent and Super Potent Tablets(posted 11/16/2017)For Immediate Release PEAPACK, NJ, November 16, 2017 - Greenstone LLC, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level.
Diphenoxylate hydrochloride and atropine sulfate tablets are packaged in bottles of 100-count (NDC 59762-1061-1) and 1000-count (NDC 59762- 1061-2).
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.
The product label states that over dosage can be life-threatening and symptoms may include opioid and/or anticholinergic effects including respiratory depression, coma, delirium, lethargy, dryness of the skin and mucous membranes, mydriasis or miosis, flushing, hyperthermia, tachycardia, hypotonia, tachypnea, toxic encephalopathy, seizures and incoherent speech.
Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.
Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in pediatric patients less than 6 years of age due to the risks of respiratory and central nervous system (CNS) depression.