Recall of hydrocodone bitartrate and acetaminophen tablets
Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of hydrocodone bitartrate and acetaminophen tablets, USP 10mg/500mg. Bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.
Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages a day.
Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example, other sedating medications or certain antidepressants.
Hydrocodone bitartrate and acetaminophen 10mg/500mg tablets are indicated for the relief of moderate to moderately severe pain. The affected lots were distributed between February 20 and November 19 to wholesale distributors and retail pharmacies nationwide.
Source: US Food and Drug Administration (FDA)
Change to heparin container label
The United States Food and Drug Administration is notifying health-care professionals, caregivers, and patients about a change to the container and carton labels for heparin products. This label change will require manufacturers of Heparin lock flush solution, USP and Heparin Sodium Injection, USP to clearly state the strength of the entire container of the medication followed by how much of the medication is in one millilitre.
These modifications will eliminate the need for health-care professionals to calculate the total amount of heparin medication in a product containing more than 1ml, thereby reducing the risk of miscalculations that may result in medication errors.
Heparin is used to prevent blood clots from forming in people who have certain medical conditions or who are undergoing certain medical procedures that may increase the chance that clots will form, or to stop the growth of clots that have already formed in the blood vessels and to prevent blood clots from forming in catheters that are left in veins over a period of time.
Health-care professionals, caregivers, and patients should be aware that that there will be a transition period before and after the official implementation date on May 1, 2013, during which both the current heparin container labels and the revised heparin container labels will be available in the marketplace. To minimise the potential for medication errors, users should consider separating the supplies of 'current' and 'revised' labelled heparin, and use all of the supplies of the 'current' heparin before using products with the 'revised' container label
Source: US Food and Drug Administration