Status
Terminated
Drug Enforcement D-0153-2024
Failed Content Uniformity Specifications
Classification
Class I
Report Date
December 27, 2023
Termination Date
July 10, 2024
Product Information
- 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
- Product quantity
- 3718 saleable units
- Reason for recall
- Failed Content Uniformity Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Address
-
341 Mason Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0153-2024
- Event ID
- 93224
- Recall initiation date
- October 23, 2023
- Center classification date
- December 20, 2023
- Code info
- Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
- More code info
- —