Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

From Drugs.com - November 16, 2017

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall - Possible Sub Potent and Super Potent Tablets

[Posted 11/17/2017]

AUDIENCE:Pharmacy, Risk Manager, Patient

ISSUE: Greenstone, a wholly owned subsidiary of Pfizer Inc., is voluntarily recalling multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets, USP to the consumer level. Greenstone initiated this recall because product from these lots has the potential to be super potent or sub potent. Products were distributed nationwide to wholesalers/retailers from November 2016 through June 2017 in the United States. See the recall notice for affected lot numbers.

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. Respiratory depression has been reported up to 30 hours after ingestion and may recur despite an initial response to narcotic antagonists. 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 areimprobable. If a patient was to receive a sub potent table, symptoms may not be controlled. To date, there have been no reports of adverse events related to this recall.

BACKGROUND: Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older.

Continue reading at Drugs.com »