Recall Enforment Report D-1139-2015

Drug Recall Enforcement Report Class III voluntary initiated by West-Ward Pharmaceutical Corp., originally initiated on 05-13-2015 for the product Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25. The product was recalled due to failed impurities/degradation specifications; 12 month stability testing (expansion of res #70548).. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	71378 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1139-2015 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Fentanyl Citrate Inj., USP, CII, 250 mcg/5 mL (50 mcg/mL) (0.05 mg/mL), Rx Only, For IV or IM Use Preservative Free, 25 X 5 mL Single Dose Vials per Carton, Manufactured by: West-Ward, Eatontown, NJ 07724 USA, NDC 0641-6028-25.
Reason For Recall	Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548). What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	14,649 Cartons Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-24-2015
Recall Initiation Date	05-13-2015 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	04-06-2016 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	West-Ward Pharmaceutical Corp.
Code Info	Lot #: 043410, Exp 04/2015; 053391, Exp 05/2015; 073340, Exp 07/2015; 083330, 083333, 083335, Exp 08/2015; 093319, 093321, 093323, Exp 09/2015; 103316, 103318, Exp 10/2015 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0641-6024-01; 0641-6024-10; 0641-6027-01; 0641-6027-25; 0641-6025-01; 0641-6025-10; 0641-6028-01; 0641-6028-10; 0641-6028-25; 0641-6026-01; 0641-6026-05; 0641-6029-01; 0641-6029-25; 0641-6030-01; 0641-6247-01; 0641-6247-25; 0641-6248-01; 0641-6248-10; 0641-6249-01; 0641-6249-10
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products