Allergan has expanded its December 2017 voluntary recall of INFeD (iron dextran injection) 50mg/mL at the retail level. The recall was initiated due to product stability testing results that did not meet specifications for iron content.
The updated recall adds 6 more lots to the original list of 2 lots. The full list of affected products are:
- Lot #15W05A (Exp 2/2018)
- Lot #17W01A (Exp 12/2019)
- Lot #16W02A (Exp 12/2018)
- Lot #16W05A (Exp 01/2019)
- Lot #16W13A (Exp 4/2019)
- Lot #17W02A (Exp 12/2019)
- Lot #17W09A (Exp 3/2020)
- Lot #17W15A (Exp 6/2020)
INFeD injection, a hematinic agent, is indicated to treat iron deficiency where oral therapy is unsatisfactory or impossible. It is intended for intravenous (IV) or deep intramuscular (IM) injection as iron dextran gets absorbed into the capillaries and the lymphatic system. The iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is bound to the available protein moieties to form hemosiderin or ferritin and helps replenish hemoglobin and depleted iron stores.
Adverse health consequences related to the out-of-specification stability are considered to be remote, according to the Company.
For more information call (800) 433-8871 or visit Allergan.com.