FDA (Drugs) recall action 73537
The FDA (Drugs) publishes a recall like this one as 7 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 7 pages.
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Superpotent Drug: one ingredient was found to be above assay specification.
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.
Meditech Laboratories is recalling Formula 4 Injection vials due to incomplete data regarding production sterility.
Meditech Laboratories is recalling Formula 2 vials because an active ingredient expired before the labeled Beyond Use Date.
Meditech Laboratories is recalling Formula 3 Injection vials because the active ingredient expired before the labeled Beyond Use Date.
Meditech Laboratories is recalling 1,320 vials of Formula 1 Injection because the active ingredient expired before the labeled Beyond Use Date.
Meditech Laboratories is recalling Formula 9 Injection vials due to incomplete production data regarding sterility assurance.
Meditech Laboratories is recalling Formula 0 Injection due to incomplete production data regarding sterility assurance.
Meditech Laboratories is recalling Formula 2 Injection vials because one ingredient exceeded assay specifications, making the drug superpotent.