FDA (Devices) recall action 80813
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies with anaerobic microorganisms.
Remel Inc is recalling Remel Thioglycollate Medium (Ref 05152) because products intermittently failed performance testing during stability studies.
Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies.