Amikacin Injection Lots Recalled Due to Glass Particulate Presence

Teva is recalling 7 lots of its amikacin sulfate injection 500 mg/2 mL (250 mg/mL) and 1 gram/4 mL (250 mg/mL) vials because of the potential presence of glass particulate matter.

Intravenous (IV) amikacin sulfate is an aminoglycoside antibiotic typically used to treat serious infections caused by strains of Gram-negative bacteria, though it has also shown effective in staphylococcal infections. It’s supplied as 2-mL and 4-mL vials packaged in shelf 10-packs of 500 mg/2 mL (250 mg/mL) and 1 gram/4 mL (250 mg/mL) vials.

Patients who are given any IV drug containing glass particulate may be prone to local irritation and swelling. More serious adverse effects are blood vessel blockage and clotting, which may become life threatening.

For that reason, pharmacists should check to see whether they’re stocking the following lots that may contain glass particulate matter:

Lot #

Exp. Date

Strength

Vial Size

NDC# (Individual Pack)

NDC# (Shelf Pack - carton of 10 vials)

2381114

11/2016

1 gm/4 mL (250 mg/mL)

4 mL

0703-9040-01

0703-9040-03

2771114

11/2016

1 gm/4 mL (250 mg/mL)

4 mL

0703-9040-01

0703-9040-03

4760915

9/2017

1 gm/4 mL (250 mg/mL)

4 mL

0703-9040-01

0703-9040-03

7080315

3/2017

500 mg/2 mL (250 mg/mL

2 mL

0703-9032-01

0703-9032-03

7400315

3/2017

500 mg/2 mL (250 mg/mL)

2 mL

0703-9032-01

0703-9032-03

7410315

3/2017

500 mg/2 mL (250 mg/mL)

2 mL

0703-9032-01

0703-9032-03

7980415

4/2017

500 mg/2 mL (250 mg/mL)

2 mL

0703-9032-01

0703-9032-03

Teva has issued an Urgent Drug Recall letter to its direct customers and arranged for recalled products to be returned to Inmar. Any distributors or facilities with recalled items should stop use and quarantine them immediately. Affected customers with questions can contact Teva at 800-545-8800.