Recalls / Class III
Class IIID-0172-2017
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
- Brand name
- Sodium Ferric Gluconate Complex In Sucrose
- Generic name
- Sodium Ferric Gluconate Complex In Sucrose
- Active ingredient
- Sodium Ferric Gluconate Complex
- Route
- Intravenous
- NDC
- 0143-9570
- FDA application
- ANDA078215
- Affected lot / code info
- Lot #: 152032.1, Exp. Date. 2/2017
Why it was recalled
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Recalling firm
- Firm
- West-Ward Pharmaceuticals Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 401 Industrial Way West, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 5,142 Shelf-packs
- Distribution pattern
- US nationwide
Timeline
- Recall initiated
- 2016-11-17
- FDA classified
- 2016-12-08
- Posted by FDA
- 2016-12-14
- Terminated
- 2018-04-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0172-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.