May 2015 FDA Recall Fentanyl Citrate by West-ward Pharmaceutical Corp. (D-1139-2015 - Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).)
This Class III drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on May 13, 2015 for the product Fentanyl Citrate. The FDA reported the reason for recall as failed impurities/degradation specifications; 12 month stability testing (expansion of res #70548).. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1139-2015
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
05-13-2015
06-24-2015
14,649 Cartons
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-Ward Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-06-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
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
