Extremely drug-resistant germ found in eye drops infects 55 in 12 states; 1 dead

FDA approval has literally nothing to do with production batches or safety. That solely refers to the claim of the product. FDA approval means Product X will have Y affect, NOT that Batch 4916 of Product X is safe for consumption.

You do not get FDA approval for every batch you produce, you get FDA approval on a product and then you produce batches of it after the fact. The company must comply with all cGMP requirements and pass audits otherwise products will get embargoed. If consumers report health issues or what have you to the FDA they will also recall production batches. But they at no point certify under the label of the FDA that a certain production batch is safe.

/r/Health Thread Parent Link - arstechnica.com