November 2016 FDA Recall Sodium Ferric Gluconate Complex In Sucrose by West-ward Pharmaceuticals Corp.
D-0172-2017 - Subpotent Drug

This Class III drug recall was voluntarily initiated by West-ward Pharmaceuticals Corp. on November 17, 2016 for the product Sodium Ferric Gluconate Complex In Sucrose. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0172-2017

Reason for Recall
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Initiated
11-17-2016
Reported
12-14-2016
Quantity
5,142 Shelf-packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75784
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-19-2018
Product Description About Product Description
Full technical description of the product.
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01

Batch or Lot Expiration Information

Lot# : 152032.1, Exp. Date. 2/2017

Affected Packages Involved in this Recall

0143-9570-01 Sodium Ferric Gluconate Complex In Sucrose
0143-9570-10 Sodium Ferric Gluconate Complex In Sucrose