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.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.
Although there were no defects identified in these products, as a conservative measure, a recall is being initiated.
Compounded Sterile Products by Phar MEDium Services: Recall - Lack of Sterility Assurance(posted 1/2/2018)Phar MEDium Services is voluntarily recalling certain lots of drug products to the hospital/user level due to a lack of assurance of sterility.
Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.
Patients and healthcare providers with questions regarding this recall can contact Phar MEDium Services Clinical Pharmacist at (847) 457-2220, Monday through Friday, between 8am and 5pm Central Standard Time or via e-mail at [email protected]
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.