Recalls / Class I
Class ID-0153-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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
- Affected lot / code info
- Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Why it was recalled
Failed Content Uniformity Specifications
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 3718 saleable units
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-10-23
- FDA classified
- 2023-12-20
- Posted by FDA
- 2023-12-27
- Terminated
- 2024-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0153-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.