February 10, 2018

Drug Recalls Impacting Comp

Senna Laxatives Recalled After Finding NSAIDs in Bottles

Magno-Humphries Laboratories, Inc., voluntarily recalled one lot of Senna Laxative tablets, 8.6mg Sennosides, after it was discovered that bottles labeled as Senna Laxatives actually contained Naproxen Sodium 220mg, a pain reliever and nonsteroidal anti-inflammatory drug (NSAID).

Unintentional consumption of naproxen could result in fatal adverse events in patients with underlying illnesses, allergies, or cardiac, gastrointestinal, hepatic, and renal conditions, as well as patients who have recently undergone cardiac bypass graft surgery.

Patients may inadvertently overdose by taking another NSAID concurrently, thus increasing the risk for NSAID associated adverse events, including myocardial infarction, stroke, congestive heart failure, renal toxicity, bleeding, ulceration, or perforation of the stomach or the intestines.

NSAIDs are commonly used in workers' compensation to help manage pain, as are laxatives to treat opioid-induced constipation.

For further information, read the FDA's safety alert.

PharMEDium Services Expands Recall of Compound Products Due to Lack of Sterility Assurance

In late December, PharMEDium Services LLC issued a recall of several compounded products due to a lack of sterility assurance. That recall notice was then expanded to include even more drug products.

A retrospective review of all commercially distributed product lots compounded in a Memphis location indicated that a total of 55 lots of different products impacting 25,327 units had two unsuccessful media fills, which test whether the aseptic procedures of manufacturing are adequate to prevent contamination during production.

Specific to workers' compensation, the original recall included several compounded opioid products, including various lots of fentanyl, morphine, and hydromorphone compounds, along with certain lots of benzodiazepine compounds that included midazolam.

The expanded recall now includes all lots within expiry from PharMEDium's Memphis, Tennessee facility. Those in possession of any of the affected medications that are being recalled should immediately quarantine the product, discontinue use and destroy them. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

For further information, see the expanded FDA recall notice.

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