Drug Safety Alerts

Pantoprazole Sodium for Injection 40 mg Class I Recall

2/14/18

On February 14, 2018, the United States Food and Drug Administration (FDA) issued a notice regarding a Class I recall of pantoprazole sodium for injection 40 mg (NDC # 55150-0202-10 carton of 10 vials and NDC # 55150-0202-00 single vial). This recall was issued due to the presence of particulate matter. One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass.

This recall affects lot number CPO170035 exp. 05/19. No other lots are affected by this recall.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics has not received reports of any adverse events or identifiable safety concerns attributed to this recall.

This recall was originally issued on December 19, 2017 to the hospital/retail-level. The FDA classified this as a Class I Recall on February 14, 2018.

Pantoprazole Sodium for Injection 40 mg per vial, is used for short term treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis and pathological hypersecretion including zollinger-ellison syndrome.The product can be identified as ‘vial stoppered with grey slotted rubber stopper and sealed with aluminum seals having Sky Blue color polypropylene disc’. AuroMedics commenced shipping the product to customers on August 7, 2017 and was distributed to wholesalers and/or hospitals nationwide.

AuroMedics Pharma LLC is notifying its distributors and customers by recall letters and is arranging for return/replacement etc. of all recalled product. Consumers/distributors/retailers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact the Aurobindo Customer Service at 1‑866-850-2876, Monday through Friday, 9:00 am to 5:00 pm (ET). You may also contact the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.