FDA (Drugs) recall action 84672
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.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
The agency’s own wording, quoted from the enforcement report.
Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection due to cGMP deviations and similarity to a previously rejected out-of-specification lot.
Sun Pharmaceutical Industries is recalling Testosterone Cypionate for Injection due to cGMP deviations and similarity to a previously rejected lot.