D-0153-2024 Class I Terminated
FDA drug recall D-0153-2024 was initiated by The Harvard Drug Group LLC Dba Major Pharmaceuticals And Rugby Laboratories on Oct 23, 2023 and is designated Class I. Reason for recall: Failed Content Uniformity Specifications The recall status is terminated (terminated Jul 10, 2024). Affected quantity: 3718 saleable units.
Recall Details
- Product Type
- Drugs
- Report Date
- Dec 27, 2023
- Initiation Date
- Oct 23, 2023
- Termination Date
- Jul 10, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3718 saleable units
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
Reason for Recall
Failed Content Uniformity Specifications
Distribution Pattern
Nationwide in the USA
Code Information
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0153-2024
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026