Status
Terminated
Drug Enforcement D-1658-2012
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
Classification
Class II
Report Date
August 29, 2012
Termination Date
November 23, 2012
Product Information
- Product description
- Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
- Product quantity
- N/A
- 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
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- VistaPharm, Inc.
- Address
-
7265 Ulmerton Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1658-2012
- Event ID
- 62893
- Recall initiation date
- April 6, 2011
- Center classification date
- August 21, 2012
- Code info
- Lot 202800, NDC 66689-035-50
- More code info
- —