Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30
Summary
The FDA issued a Class III for Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x by Acella Pharmaceuticals, LLC. Reason: Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode..
Details
Source
Drug Recall
External ID
D-0070-2023
Action Date
2022-11-30
Status
Terminated
Category
drug
Product Description
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Lot/Code Info: Lot: E026A001 Exp. 06/2023
Quantity Affected: 637 cartons
Reason for Recall
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-14
Company
Alpharetta, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 24 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Acella Pharmaceuticals, LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Acella Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Acella Pharmaceuticals, LLC have FDA actions?
Acella Pharmaceuticals, LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0070-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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