Approximately 10,200 bottles of Zydus Cadila's allergy relief medication could hold another pill than the company originally intended to put in.
The Indian drug manufacturer voluntary recalled the containers in the United States on May 8, 2014, after one consumer discovered the high blood pressure medication atenolol in a batch of Promethazine hydrochloride, according to U.S. Food and Drug Administration information Reuters obtained Friday.
A Zydus spokeswoman told Reuters that the company approached the matter carefully.
"This was a voluntary recall by the company as a precautionary measure," the spokeswoman said. The capsules, which expire Sept. 2015, could give consumers medically or temporarily curable symptoms, per the recall's class II categorization.
Six other Indian companies have also pulled back drugs, including Wockhardt Ltd., Ranbaxy Laboratories Ltd, Dr. Reddy Laboratories Ltd, Lupin Ltd, Sun Pharmaceutical Industries Ltd., and Glenmark Pharmaceuticals Ltd.
Ranbaxy recalled 29,790 packs of over-the-counter allergy medication due to defective packaging issues, according to FDA recall information. The affected medications included 10 and 240 milligrams of loratadine and pseudoephedrine sulfate extended release tablets.
"An unacceptable level of blister defects have been identified in loratadine and pseudoephedrine sulfate extended release tablets," the USFDA said.
The products were sold at drug stores in California, Ohio, Pennsylvania, Rhode Island and Texas. These included Krogers, Mckesson, AmerisourceBergen, H-E-B and Rite Aid. CVS Pharmacy shipped them to the pharmacies.
According to Reuters, the FDA has reportedly kept its eye on Indian pharmaceutical companies after banning product shipments from reputable manufacturing plants such as Ranbaxy and Wockhardt, where the administration discovered quality control issues.
Promethazine hydrochloride helps ease allergic disorders, nausea, vomiting and sleeping issues. It's also used as a pre-operative sedation.
Atenolol helps adults manage heart disease angina and hypertension in the long term, Techsonia reported.
Zydus Pharmaceuticals provides medication to Cadila Healthcare.
