Why it was recalled
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 152032.1, Exp. Date. 2/2017
Where it was sold
US nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0172-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 17, 2016
- FDA report date
- Dec 14, 2016
- Quantity
- 5,142 Shelf-packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Pharmaceuticals Corp.
Original FDA data
Every field from FDA enforcement report D-0172-2017, exactly as published.
Show all FDA fields
- City
- Eatontown
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75784
- Address
- 401 Industrial Way West
- Code information
- Lot #: 152032.1, Exp. Date. 2/2017
- Postal code
- 07724-2209
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0172-2017
- Classification
- Class III
- Recalling firm
- West-Ward Pharmaceuticals Corp.
- Product quantity
- 5,142 Shelf-packs
- Termination date
- Apr 19, 2018
- Reason for recall
- Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US nationwide
- Recall initiation date
- Nov 17, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2016