The Food and Drug Administration (FDA) is alerting providers about a voluntary recall of sterile drug products due to lack of sterility assurance.
The unexpired sterile products are manufactured by Bella Pharmaceuticals and were distributed to health care facilities across the country. Affected products include lots distributed between April 17 and Aug. 10 and could be packaged in a syringe, vial, or eye dropper.
If not sterile, administration of the product could cause serious, potentially life-threatening infections. The manufacturers said it has not received any reports of adverse events.
Bella Pharmaceuticals is notifying its customers and arranging for the return of all affected products.
FDA advises health care professionals to report adverse reactions or quality problems associated with these products to the agency’s MedWatch Safety Information and Adverse Event Reporting Program.
Contact Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.