FDA (Drugs) recall action 86280
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
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.
Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.
Bayshore Pharmaceuticals is voluntarily recalling 3,984 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.