If you or a loved one takes Sun Pharmaceuticals' generic brand of Wellbutrin, the well known antidepressant drug, be advised that the manufacturer has issued a recall ahead of the FDA. Over 30,000 bottles of the generic medication are being recalled due to problems with the dissolution specifications, or how quickly the drug dissolves.
The medication being recalled is sold under the generic name of bupropion hydrochloride extended-release. The recall only applies to the 150mg tablets that were produced in the company's manufacturing facility in Halol, India. Although a recall has been issued, the recalled drug is not likely to cause injury.
Non-Life Threatening Recall
Bupropion hydrochloride, better known as Wellbutrin, is a common antidepressant, that also has been used to help smokers quit, as well as for ADHD. The recall was voluntarily issued by Sun Pharmaceuticals as a result of discovering that the drug was not dissolving at the intended rate. The drug's 100mg and 300mg varieties had been recalled in 2013 for the same issue as well as additional problems.
Even though the recall has been issued by the company, it is important to note that this is not a life threatening situation. The FDA has categorized the recall as a Class III recall, which means that while the medication has violated some regulations, the medication is not likely to cause adverse health consequences.
Sun's History of Problems
Sun Pharmaceuticals' Halol, India facility has had numerous issues over the past few years, but other facilities have seen recalls as well. Sun's facility in Hungary issued a voluntary recall earlier this year, and last year the U.S. facility in Philadelphia also issued recalls for various medications. One of the major recalls from the Philly plant involved a drug that included an active ingredient that the facility knew to be contaminated, but allowed it to be made and distributed regardless.
Sun sold the Philadelphia facility in June to another pharma company, however, as part of the sale they committed to bringing the facility within FDA regulations. Currently, Sun is asking the FDA to return to the Halol facility to re-inspect as they believe that all violations have been resolved.