Ethosuximide Oral Solution (PAI Holdings) – CGMP Violation (2021)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
Brand
PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Lot Codes / Batch Numbers
Lot: C9BC Exp. 31OCT2022
Products Sold
Lot: C9BC Exp. 31OCT2022
PAI Holdings, LLC. dba Pharmaceutical Associates Inc is recalling Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, due to Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026