Class II
Terminated
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- Company
- Vistapharm, Inc.
- Recall Initiated
- September 30, 2011
- Posted
- August 8, 2012
- Recall Number
- D-1440-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 27,221 unit dose cups
- Firm Location
- Largo, FL, United States
Reason for Recall
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.
Distribution
Nationwide
Lot / Code Info
Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
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