Ethosuximide Oral Solution Recalled Due to Lack of CGMP Compliance
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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any illnesses or injuries from the potential carry-over contamination, and the hazard is related to a manufacturing process control issue rather than a confirmed contamination event. The recall appears to be precautionary in nature based on the CGMP violation.
Plain-English summary
PAI Holdings, LLC (dba Pharmaceutical Associates Inc) is recalling Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz bottles, NDC 0121-0670-16. The recall affects 75 cases (6 bottles per case) with Lot C9BC and expiration date of 31 October 2022. The product was distributed nationwide in the USA.
The recall was initiated due to a lack of current good manufacturing practice (CGMP) compliance, specifically related to the potential for carry-over of Senna Syrup during manufacturing.
Consumers who have this medication should contact their healthcare provider or pharmacist for guidance. Healthcare providers should consult with their patients about the recall and advise them on appropriate next steps for their seizure management.
The recalled product
- Product
- ETHOSUXIMIDE (ETHOSUXIMIDE)
- Brand
- ETHOSUXIMIDE
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Hazard
- cgmp-violation
- cross-contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: C9BC Exp. 31OCT2022
UPCs (1)
- 0301210670169
Distribution
Distributed nationwide across the United States.
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