FDA (Drugs) recall action 98575
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.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
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.
Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes for lack of assurance of sterility, following an FDA observation of deficiencies in visual inspection at the contract manufacturing site.
Cipla is recalling Lanreotide Injection 120 mg/0.5 mL prefilled syringes supplied with a safety needle, citing lack of assurance of sterility. 54,583 syringes are affected.