Recalls / Class II
Class IID-1440-2012
Product
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- Affected lot / code info
- Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Why it was recalled
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 27,221 unit dose cups
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2011-09-30
- FDA classified
- 2012-08-02
- Posted by FDA
- 2012-08-08
- Terminated
- 2013-12-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1440-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.