Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC
Summary
The FDA issued a Class II for Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmac by PAI Holdings, LLC. dba Pharmaceutical Associates Inc. Reason: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup..
Details
Source
Drug Recall
External ID
D-0723-2021
Action Date
2021-08-18
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot: C9BC Exp. 31OCT2022
Quantity Affected: 75 cases (6 bottles/case)
Reason for Recall
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Greenville, SC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
PAI Holdings, LLC. dba Pharmaceutical Associates Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PAI Holdings, LLC. dba Pharmaceutical Associates Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PAI Holdings, LLC. dba Pharmaceutical Associates Inc have FDA actions?
PAI Holdings, LLC. dba Pharmaceutical Associates Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0723-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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