Qualitest, a subsidiary of Endo Health Solutions (Nasdaq: ENDP), a US-based diversified healthcare company, has launched a voluntary, nationwide recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13. The recall began just this past Monday, September 10, 2012.
The recall was initiated when it became apparent that, possibly, some of the tablets from lot C1440512A may exceed the weight specifications and run the risk of being overly potent with the ingredients of hydrocodone bitartrate and acetaminophen. With bottles from the affected lot potentially having higher dosages of acetaminophen than ascribed on the labels, consumers have been put at risk of overdosing on the ingredients in the medication.
One of the primary risks of over-medicating with acetaminophen is an affected liver toxicity. This danger becomes especially significant for patients who are already taking other medications that contain acetaminophen, patients who suffer from liver dysfunctions, or those who have at least three alcoholic drinks per day. In the most extreme cases, an excess of acetaminophen could lead to severe liver damage, the need of a liver transplant, or death.
According to a study conducted by the US National Library of Medicine and National Institutes of Health, acetaminophen overdoses account for about 56,000 emergency room visits annually, along with 26,000 hospitalizations. National mortality files show that an average of 458 people die from a reaction to acetaminophen, with about 100 of those deaths being unintentional.
With higher doses of hydrocodone, the concerns lay within the conceivable increase in the frequency or intensity of the side effects like sedation or respiratory depression. This hazard stands as particularly meaningful for elderly patients, patients who are enduring some kind of severe kidney or liver impairment, or are also taking interceding medications such as other sedatives or certain antidepressants. The most frequently reported side effects of hydrocodone are pain, anxiety, and nausea. These effects can sometimes be followed by fatigue or vomiting.
As of today, there have been no reported injuries or major side effects. When properly used, hydrocodone bitatrate and acetaminophen 10mg/500mg tablets are intended to relieve moderate to moderately severe pain. The affected lot, identifiable by its December 2013 expiration date, was distributed nationally between the dates of May 14 and August 3 2012 to wholesale distributors and retail pharmacies. The lot number should be easily recognizable on the side of the manufacturer’s bottle. The medication comes in the form of pink, capsule-shaped tablets with 3600 embossed on one side and V placed on the other. According to the Food and Drug Administration, consumers who have purchased the lot in question should contact Qualitest at 1.800.444.4011. Those who are unsure if they have purchased the distorted batch should immediately get in contact with their pharmacy or personal healthcare professional. The recall was done in coordination with the FDA.
If there questions or thoughts that you think you, or someone close to you, should have addressed regarding a potential drug injury, please feel free to contact Altman and Altman at your earliest convenience. There are professionals present who can help address your concerns