Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).
Drug Recall
Official source record
- Recall number
- D-1438-2012
- Event ID
- 62627
- Classification
- Class II
- Status
- Terminated
- Recalling company
- West-Ward Pharmaceutical Corp.
- Reason for recall
- Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
- Report date
- August 8, 2012
- Recall initiation date
- April 13, 2012
- Termination date
- January 16, 2015
- Distribution pattern
- All lots were distributed throughout the US.
Drug product identifiers
- Manufacturer
- West-Ward Pharmaceuticals Corp
- Brand name
- FOSPHENYTOIN SODIUM
- Generic name
- FOSPHENYTOIN SODIUM
- Substance name
- FOSPHENYTOIN SODIUM
- Product NDCs
- 0143-9782; 0143-9788
- Package NDCs
- 0143-9703-10; 0143-9782-01; 0143-9782-10; 0143-9788-01; 0143-9788-25
- Routes
- INTRAMUSCULAR; INTRAVENOUS
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to the FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
Do not start, stop, or change any medication based on this page. Follow the instructions published by the FDA and the recalling company (see the source links below), and talk to your pharmacist or physician if you have questions about a specific medication.
Where can I find more official information?
The source links below, published by the FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.
