West Columbia Pharmaceutical Company Recalls Over 2 Million Doses of Generic Drugs | Colombia Business
WEST COLUMBIA – Nephron Pharmaceuticals has issued a recall of more than 2 million doses of 20 generic drugs it produces at its West Columbia manufacturing facility.
Drugs that relieve pain, reduce bleeding after childbirth, control blood pressure and are used in anesthetics are among the recalled drugs. Notices posted on the US Food and Drug Administration website indicate that various pharmaceutical products are being recalled due to “lack of sterility assurance”.
Sterility assurance refers to the likelihood that bacteria, viruses or other microorganisms are unable to survive the sterilization process. Federal regulations require drug manufacturers to demonstrate a certain level of confidence in the sterility of their products.
“Out of an abundance of caution, Nephron is proactively cooperating with the Food and Drug Administration on a voluntary recall of a limited number of product lots,” CEO Lou Kennedy said in a statement. “We do not take this lightly. Although there was no impact on patient safety and there was no evidence of contamination, Nephron has decided, in the interest of patients, to continue this recall process.”
FDA officials traveled to Nephron to perform what the company called “a routine inspection…after being unable to visit, due to the ongoing public health crisis caused by the COVID-19 pandemic. “.
The drugs involved in the recall are part of Nephron’s drug compounding operation, which produces in-demand and commonly used drugs for hospitals and medical clinics across the country.
Neither the FDA nor the company said what led to the concern surrounding its sterilization process, repeating only that “there was no patient safety hazard and no contamination.” Nephron did not disclose how much the recall will cost the company.
“Nephron is more confident than ever that it will learn from this and emerge stronger than ever by working hard as a team,” the company said in a statement.
The company’s drug compounding business remains in operation as the FDA continues its inspection process.
FDA officials did not respond to questions from The Post and Courier in time for the deadline.
Among the medicines recalled are: oxytocin, used to induce contractions during labor and reduce bleeding after childbirth; phenylephrine and labetalol, used to control blood pressure; ketamine hydrochloride, lidocaine, glycopyrrolate, succinylcholine chloride, rocuronium bromide, which are anesthetics, sedatives and anesthetic aids; neostigmine methyl sulfate, used to reverse the effects of muscle relaxants after surgery; epinephrine, used during cardiac arrest; calcium gluconate, used to treat calcium deficiency; sodium bicarbonate, an antacid; and hydromorphone, a pain reliever.
Nephron has sent notices to customers by certified mail and email. There is also a dedicated phone line for anyone with questions about the recall.
“The company is ready to provide the necessary resources and information to healthcare providers and patients to ensure they have everything they need and all their questions answered. They remain our top priority. “Kennedy said.
A total of 2.15 million syringes and more than 7,000 bags of drugs were involved in the recall, which the notice on the FDA’s website says is ongoing.
The recall has been listed as a Class II, the second of three classes used by federal regulators, which means the use of the drugs could have temporary adverse health consequences or the likelihood of serious health consequences is weak.
Nephron has the capacity to produce more than one billion doses of various pharmaceutical products per year, the company said. In its compounding operations, the company is licensed to manufacture some 125 types of sterile drugs, Kennedy previously told The Post and Courier.
The drugmaker has been on a wave of growth in recent years, building its sprawling campus to add production of at-home COVID-19 test kits and medical gloves, a new 110,000-square-foot wing where it will begin manufacturing chemotherapy drugs and a number of antibiotics, a new 200,000 square foot warehouse where it plans to fill vaccines, and a new subsidiary that will manufacture some of the medical devices and packaging that Nephron previously outsourced.
This is in addition to the respiratory medications the company has long been known for.
According to Kennedy, the company employs about 1,200 full-time and 2,500 part-time workers.