Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Summary
The FDA issued a Class I for Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit d by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Reason: Failed Content Uniformity Specifications.
Details
Source
Drug Recall
External ID
D-0153-2024
Action Date
2023-12-27
Status
Terminated
Category
drug
Product Description
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Lot/Code Info: Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Quantity Affected: 3718 saleable units
Reason for Recall
Failed Content Uniformity Specifications
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-23
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories have FDA actions?
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0153-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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