Anti-allergy drug recalled by Ranbaxy from US market
Ranbaxy Laboratories Ltd. is voluntarily recalling nearly 30,000 blister packs of its over-the-counter anti-allergy drug from the United States market due to defective packaging. The drug was manufactured by its arm Ohms Laboratories in New Jersey, which is the company’s only facility manufacturing generic for the United States. US FDA stated that an unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate extended release tablets, 10 mg/240 mg. The loratadine and pseudoephedrine sulfate extended release tablets being recalled carry an expiry date of September 2015. These medications are generic versions of Claritin, called loratadine, particularly the slow- release pills with added decongestant. The recall affects drugs sold in California, Ohio, Pennsylvania, Rhode Island, and Texas.
The FDA's full description of the product is "Non-Drowsy 24 hour formula allergy relief and nasal decongestant, Pseudoephedrine Sulfate, USP 240 mg, Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only." FDA classified the recall as Class II, which means that using the defective product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.