The products may be contaminated
of ConsumerAffairs
Medistat RX of Foley, Alabama, is recalling all non-expired drug products produced for sterile use.
The recalled products, which may be contaminated, were distributed nationwide between November 1, 2014, and September 3, 2015.
During a continuing inspection, Food and Drug Administration (FDA) and Alabama state inspectors observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced. Medistat ceased sterile compounding operations on September 1, 2015.
FDA has received reports of several adverse events that are potentially associated with drug products made by Medistat.
Health care professionals and patients are urged to report adverse reactions or quality problems with the use of these products to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
FDA previously inspected Medistat in September 2014 and issued a Form FDA 483.