Status
Terminated
Drug Enforcement D-1437-2012
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Classification
Class II
Report Date
August 8, 2012
Termination Date
January 16, 2015
Product Information
- Product description
- Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 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 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
- Product quantity
- a) 308,275 vials; b) 2,008,850 vials
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- All lots were distributed throughout the US.
Location & Firm
- Recalling firm
- West-ward Pharmaceutical Corp.
- Address
-
465 Industrial Way W, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1437-2012
- Event ID
- 62627
- Recall initiation date
- April 13, 2012
- Center classification date
- August 2, 2012
- Code info
- Lot #s: a) 113153.1, 113154.1, 113155.1, Exp 05/13; 113248.1, Exp 07/13; b) 103196.1, 103197.1, 103197.2, 103198.1, Exp 07/12; 103317.1, 103318.1, 103319.1, 103345.1, 103345.2, Exp 11/12; 103346.1, 103347.1, 103348.1, 103349.1, 103350.1, Exp 12/12; 113030.1, 113031.1, 113032.1, 113033.1, 113034.1, 113035.1, 113036.1, Exp 01/13; 113245.1, 113246.1, 113247.1, Exp 07/13
- More code info
- —