Class I
Terminated
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
This recall has been terminated (originally issued December 27, 2023).
- Recall Initiated
- October 23, 2023
- Posted
- December 27, 2023
- Recall Number
- D-0153-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3718 saleable units
- Firm Location
- La Vergne, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Content Uniformity Specifications
Distribution
Nationwide in the USA
Lot / Code Info
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
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