Generic drug maker Ranbaxy Laboratories Inc. is recalling 2 lots of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Amoxicillin & Clavulanate Potassium for Oral Suspension. The antibiotic is used to treat ear, nose and throat infections in children.
According to a notice on the Food & Drug Administration (FDA) Web site, there have been complaints from some U.S. customers that the oral suspension turned brown upon reconstitution, whereas the product should be white. The company said its tests showed the antibiotic met specifications, but that it decided to recall all of the lots in question as a matter of caution. The Lot numbers subject to recall are 1910779 and 1910782.
The FDA has deemed the recall a Class II recall, and said the antibiotic is unlikely to cause serious health problems. The antibiotics being recalled are set to expire in May.
Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995. The defective antibiotic was made in Ranbaxy’s Dewas, India plant. As we’ve reported previously, the FDA has banned that facility, as well as another in India, from selling some drugs in the U.S. The FDAâ€™s decision to implement the ban was made because of the agencyâ€™s concerns about the â€œseriousness and extentâ€ of violations of manufacturing standards at the facilities. Officials said they were concerned about whether the practices employed at the facilities could ensure purity of drugs they made.
The ban, which was imposed in September 2008, applies to generic versions of popular medicines such as the anticholesterol drug Zocor; Acyclovir, which treats herpes; the heartburn pill Zantac; and AIDS drugs. However, the recalled antibiotic was not among those barred from the U.S.
Ranbaxy is in talks with the FDA to get the agency to revoke the ban. It is unclear as to whether or not the antibiotic recall will impact the FDA’s decision.