Sodium Ferric Gluconate Complex in Sucrose Injection recall: Subpotent
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
Why was Sodium Ferric Gluconate Complex in Sucrose Injection recalled?
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 152032.1, Exp. Date. 2/2017
- 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
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Quantity
- 5,142 Shelf-packs
- Distribution
- US nationwide
- Recall date
- December 14, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)