FDA (Drugs) recall action 98609
The FDA (Drugs) 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.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
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.
Teva is recalling two lots of Octreotide Acetate for Injectable Suspension 10 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Teva is recalling twelve lots of Octreotide Acetate for Injectable Suspension after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
Teva is recalling nine lots of Octreotide Acetate for Injectable Suspension 20 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.