Xactdose Phenytoin Oral Suspension recall
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Why was Xactdose Phenytoin Oral Suspension 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
- Product
- Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 27,221 unit dose cups
- Distribution
- Nationwide
- Recall date
- August 8, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)