Health care providers and patients should not use compounded products marketed as sterile by Greenpark Compounding Pharmacy due to a lack of sterility assurance, the Food and Drug Administration announced today. FDA recently recommended the compounder expand its recall of a compounded ophthalmic drug to include all unexpired compounded drugs intended to be sterile and stop their production until it implements adequate corrective actions. However, the company has refused to recall the products or cease compounding sterile drugs, FDA said. 

Related News Articles

Headline
The Food and Drug Administration today approved the first interchangeable biosimilar product for Humira, a monoclonal antibody used to treat certain…
Headline
Abbott Molecular Inc. yesterday issued a recall for its Alinity m SARS-CoV-2 AMP Kits and Alinity m Resp-4-Plex AMP Kits, distributed between May 13, 2020, and…
Headline
The Food and Drug Administration and Magellan Diagnostics Inc. today expanded the ongoing recall of LeadCare II, LeadCare Plus and LeadCare Ultra Blood Lead…
Headline
The Food and Drug Administration today announced it will withdraw regulations for non-drug manufacturers who produced during the COVID-19 public health…
Headline
DeRoyal Industries recently recalled more than 2,800 procedure packs distributed in the U.S. that could expose patients to harmful levels of aluminum. The…
Headline
The Food and Drug Administration yesterday authorized the emergency use of a new over-the-counter COVID-19 antigen test. Unlike most antigen tests for at-…