Product Safety Recalls

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PHENYTOIN Recall D-0153-2024

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

PHENYTOIN Recall D-0153-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0153-2024
Event ID93224
Active SubstancePHENYTOIN
Drug RouteORAL
DistributionNationwide in the USA
Quantity3718 saleable units
Recall ReasonFailed Content Uniformity Specifications
Drug ClassificationClass I
Drug Code Info20231227
Product NDC0904-7079
Product NUIN0000175753 N0000008486 N0000191266
Pharma Class (PE)Decreased Central Nervous System Disorganized Electrical Activity [PE]
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Recall Initiation Date20231023
Report Date20231227
Classification Date20231220
Address341 Mason Rd
La Vergne, TN 37086-3606
United States
Recalling FirmThe Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Initial Notification Letter
Unique Ingredient Identifier6158TKW0C5
Drug Application NumberANDA040521
Structured Product Labeling (SPL ID)070e56f4-db77-4ead-aad9-054a1dad8507
Structured Product Labeling (SPL Set ID)76c93365-7aa0-430a-9f49-e94e10912f49
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