Ethosuximide Oral Solution USP 250 mg/5 mL recall: CGMP Deviations
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
Why was Ethosuximide Oral Solution USP 250 mg/5 mL recalled?
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: C9BC Exp. 31OCT2022
- 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
- Recalling firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Quantity
- 75 cases (6 bottles/case)
- Distribution
- Distributed Nationwide in the USA
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)