FDA (Drugs) recall action 96741
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
cGMP deviations and lack of assurance of sterility.
The agency’s own wording, quoted from the enforcement report.
BRS Analytical Services is recalling Lubricant Eye Drops Solution (Polyethylene Glycol 400 and Propylene Glycol) due to manufacturing deviations and lack of assurance of sterility. The product was distributed nationwide.
BRS Analytical Services is recalling Artificial Tears ophthalmic solution (0.5 FL OZ dropper bottles) nationwide due to manufacturing deviations and lack of assured sterility. Affected lots are Lot 126–129, 162–170, and 193–199.
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Gel 1% eye lubricant due to current Good Manufacturing Practice (cGMP) deviations and lack of assurance of sterility.
BRS Analytical Services is recalling Polyvinyl Alcohol Ophthalmic Solution 1.4% eye drops nationwide due to cGMP deviations and lack of assurance of sterility.
BRS Analytical Services is recalling Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% eye lubricant nationwide due to cGMP deviations and lack of assurance of sterility. The recalled product was distributed in 0.5 FL OZ dropper bottles across multiple lots with various expiration dates in 2025 and 2026.