Home / Recalls / West-Ward Pharmaceuticals Corp. / D-0172-2017

D-0172-2017 Class III Terminated

Recalled by West-Ward Pharmaceuticals Corp. — Eatontown, NJ

Recall Details

Product Type
Drugs
Report Date
December 14, 2016
Initiation Date
November 17, 2016
Termination Date
April 19, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,142 Shelf-packs

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

Reason for Recall

Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.

Distribution Pattern

US nationwide

Code Information

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

Other recalls by West-Ward Pharmaceuticals Corp.

  • D-0094-2018 Class III — Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (November 6, 2017)
  • D-0093-2018 Class III — Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-614 (November 6, 2017)
  • D-0147-2017 Class III — Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), R (November 4, 2016)
  • D-1045-2017 Class II — Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward P (October 3, 2016)
  • D-1515-2016 Class III — Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when recon (August 18, 2016)