Recalls / Class II
Class IID-0723-2021
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 name
- Ethosuximide
- Generic name
- Ethosuximide
- Active ingredient
- Ethosuximide
- Route
- Oral
- NDC
- 0121-0670
- FDA application
- ANDA040253
- Affected lot / code info
- Lot: C9BC Exp. 31OCT2022
Why it was recalled
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Recalling firm
- Firm
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Manufacturer
- PAI Holdings, LLC dba PAI Pharma
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1700 Perimeter Rd, N/A, Greenville, South Carolina 29605-5252
Distribution
- Quantity
- 75 cases (6 bottles/case)
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-12
- Posted by FDA
- 2021-08-18
- Terminated
- 2022-12-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0723-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.