FDA (Drugs) recall action 85183
The FDA (Drugs) publishes a recall like this one as 9 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 9 pages.
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
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.
Aurobindo Pharma USA Inc. is recalling specific lots of Gabapentin Capsules because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling specific lots of Oxycodone and Acetaminophen tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma is recalling 8,040 bottles of Levetiracetam 750 mg tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling 2,101 bottles of Phentermine Hydrochloride 15mg capsules because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling specific lots of Acetaminophen and Codeine Phosphate tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling specific lots of Simvastatin 40mg tablets because they were manufactured in an area with observed water leakage.
Aurobindo Pharma USA Inc. is recalling Mirtazapine Tablets 15mg due to water leakage observed in the manufacturing area.