Ranbaxy Laboratories on Thursday said its US subsidiary is voluntarily recalling two lots of an antibiotic drug from the American market after receiving certain complaints about them.
The company’s US arm, Ranbaxy Pharmaceuticals Inc is conducting the recall after receiving a limited number of complaints about the drug, which is in powdered form, changing colours when mixed with water to make formulations.
“Ranbaxy Pharmaceuticals Inc., Jacksonville, Florida is conducting a voluntary recall of Amoxicillin and Clavulanate Potassium for Oral Suspension, which is limited to Lot No 1910779 and 1910782 with expiry of May 2010 that is currently available in the US market,” Ranbaxy Laboratories said in a statement.
Based on a limited number of complaints from the US market that describe a change in colour of the product on reconstitution, the company has decided to recall all the lots in question as a matter of caution, given its commitment to the health and safety of patients, it added.
The recall is being carried out at the retail level and is being conducted with the full knowledge of the US health regulator Food and Drug Administration (FDA), it said.
The company, however, declined to comment on the impact of the recall on its earnings, but according to industry experts, “it will be negligible.”
Earlier in July last year, on recommendations of the US FDA, Ranbaxy had recalled a single lot of Sotret Isotretinoin capsules in 40 mg strength, used in the treatment of acne (a type of skin disease) from the US market.
Ranbaxy had got the USFDA nod to market the drug in 2003 and it has annual sales of around USD 415 million in the US.
The Gurgaon-based company is yet to sort out issues with the US FDA regarding good manufacturing-practices compliance of its two units located in Dewas, Madhya Pradesh and Paonta Sahib, Himachal Pradesh.