FDA (Drugs) recall action 88392
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
The agency’s own wording, quoted from the enforcement report.
PAI Holdings is recalling Nystatin Oral Suspension nationwide due to a lack of Current Good Manufacturing Practice (CGMP) controls that could allow carryover of Senna Syrup into the product.
Pharmaceutical Associates Inc. is recalling Cimetidine Hydrochloride Oral Solution 300 mg/5 mL due to a lack of Current Good Manufacturing Practice (CGMP) and potential carryover of Senna Syrup.
PAI Holdings is recalling Ethosuximide Oral Solution 250 mg/5 mL (Lot C9BC, expiration 31 October 2022) distributed nationwide due to potential carry-over contamination from Senna Syrup related to lack of current good manufacturing practices.