Drug 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
D-0172-2017
Product summary
- Event
- Event 75784
- Status
- Terminated
- Classification
- Class III
- Quantity
- 5,142 Shelf-packs
- Official record key
drug-enforcement:D-0172-2017
Official wording
Reason: Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Code information: Lot #: 152032.1, Exp. Date. 2/2017
Distribution pattern: US nationwide
Derived failure modes
-
Potency or specification failure
Subpotent