Ranbaxy Issues Drug Recall for OTC Allergy Medication
Generic drug manufacturer Ranbaxy has issued another drug recall, this time for an over-the-counter allergy medication because of imperfections in the packaging.
According to the FDA, the drug recall was due to “an unacceptable level of blister defects,” or problems with the pills’ packaging. The company began the recall in February of this year.
The allergy medications under the drug recall are a generic form of Claritin, called loratadin. The pills have an expiration date of September 2015, and are slow-acting anti-allergy pills with an added decongestant. The product was sold in California, Ohio, Pennsylvania, Rhode Island, and Texas at CVS, Discount Drug Mart, Kroger, Sunmark, Good Neighbor Pharmacy, H-E-B, and Rite Aid. The drug recall covers almost 30,000 packages of loratadin.
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.”
The Class II drug recall means that the company voluntarily recalled the product. However, Ranbaxy has come under fire with the FDA several times in the last year, including forced recalls of generic Lipitor due to a mix-up in pills in the bottle.
Ranbaxy also agreed last year to pay a $500 million criminal penalty to US drug regulators after a year-long investigation.
On Monday, May 13th, Ranbaxy entered a guilty plea and agreed to pay the largest fine against a pharmaceutical company in US history, for serious violations of the Federal Food, Drug, and Cosmetics Act, which prohibits the sale of impure drugs.
Ranbaxy admitted that the company sold impure and adulterated batches of drugs, produced at two manufacturing sites in India. Among the impure drugs were generic versions of Lipitor, an antibiotic, and medications for acne, epilepsy, and nerve pain.
So far, it is unknown of the generic drugs directly caused any health complications in patients. Last November, the FDA recalled generic Lipitor because tiny glass particles had been found in the drug, but the administration said they had received no reports of patients being injured by the generic drug.
Ranbaxy admitted to multiple deficiencies, including improperly storing drug samples waiting for testing, selling medications in the US that failed purity tests, and delaying a voluntary recall of medication despite the knowledge that the drug would not maintain its shelf life.
The pharmaceutical manufacturer also admitted to making false statements to the FDA between 2006 and 2007. They claimed to have falsified annual reports about test dates, which are designed to detect drug impurities and appropriate storage conditions. In some cases, according to Ranbaxy, tests were conducted weeks or even months after the company said they had been performed. In other cases, the company had ignored the prescribed testing interval.
The Strom Law Firm Can Help with Dangerous Drug Recall Cases
The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using dangerous drugs, tainted dietary supplements, or medical devices that did not receive a proper drug recall, dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800