FDA (Drugs) recall action 77065
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
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.
Mylan Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to chemical contamination from paint thinner vapors during facility repairs.
Mylan Pharmaceuticals is recalling Tarina Fe 1/20 tablets due to chemical contamination from paint thinner vapors during manufacturing.