A drug manufacturer is initiating a recall of a batch of blood pressure medication after discovering the presence of a foreign tablet during production.
Foreign Drug on Packaging Line
On September 29, KVK-Tech, Inc. announced its voluntary nationwide recall of one lot of 10-milligram betaxolol tablets distributed across retailers and wholesalers in the U.S. According to a recall notice published by the U.S. Food and Drug Administration (FDA) on October 3, the action was made as a precautionary measure against the potential presence of oxycodone hydrochloride tablets.
As described in the notice, the betaxolol pills are white, round, and film-coated, with one side showing a "K" and the number "13". These were packaged in white plastic bottles filled with 100 tablets each. The affected lot has batch number 17853A and an expiration date of June 2027.
The company discovered a five-milligram oxycodone hydrochloride on the packaging line during the line clearance when the lot was packaged. Meanwhile, KVK-Tech has not received any reports of a "foreign tablet" found in a bottle of betaxolol.
Betaxolol is a drug taken as medication for high blood pressure, while oxycodone HCl is used as a pain reliever. The two pills are similar in appearance, and their minor difference is not likely noticed by a regular user of the 10 mg betaxolol pill. This means that inadvertent exposure to a controlled substance like oxycodone could result in respiratory depression, a serious health risk.
The recall notice mentions that the betaxolol package insert warns about the slowing of heart rate in elderly patients, which is exacerbated by inadvertent opioid administration. Furthermore, patients prescribed low-dose betaxolol could have compromised heart and lungs, likely exacerbated by an opioid. Patients at risk of overdose are also likely to be negatively affected by receiving oxycodone, which is currently famous as a powerful narcotic drug (opioid).
A recall notice letter was issued by KVK to distributors and customers through email and overnight mail on September 27. Since a few bottles containing oxycodone could have been sent to retail pharmacies, the company will facilitate the return of the recalled product.
FDA also warns users to stop using the pill if they received the recalled batch, encouraging them to return them to KVK-Tech immediately. Users are assured that they will be reimbursed for purchasing the medication.
Risks of Narcotic Abuse and Addiction
Drug addiction is not just about illegal substances since a person can also be addicted to prescription or illegally obtained narcotic pain medications or opioids. In the U.S., narcotic addiction is already epidemic, contributing to two-thirds of all drug overdose deaths in 2018.
Narcotics refer to a class of drugs commonly called opioids, a type of prescription pain medication that ranges in potency from moderate to very powerful. Their ability to relieve pain is attributed to their nature of binding the receptors in the central nervous system, which are responsible for the perception of pain and pleasure.
In the U.S., most narcotics are categorized as Schedule II drugs, meaning they have medical uses but are also habit-forming with a high potential for abuse. They can also fall outside this classification system if they are illegally acquired, such as heroin, an illicit street drug.
RELATED ARTICLE: Opioid Overdose: What is Narcan or Naloxone and How Can It Help With Heroin Overdosage?
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