May 11, 2018
AuroMedics Pharma is recalling 2 types of antibiotic injections for intravenous infusion due to a lack of sterility assurance. According to the May 9, 2018, US Food and Drug Administration (FDA) Enforcement Report, a customer found leaking bags and mold between the outer bag and overwrap.
The recall, which was categorized Class II by the FDA May 3, 2018, affects levofloxacin and linezolid injections manufactured by Aurobindo Pharma. Class II designations warn that use of the drug could cause temporary or medically reversible adverse health consequences. The likelihood of serious harm is remote.
Included in the recall are:
- levofloxacin in 5% dextrose injection, 250 mg levofloxacin (5 mg/mL) in 50 mL of 5% dextrose (NDC 55150-243-46), from lots CLF160002, CLF160004, and CLF160005 (Exp. 5/18); CLF160006 and CLF160007 (Exp. 6/18); CLF170027 (Exp. 7/19); and CLF170029 (Exp. 8/19).
- levofloxacin in 5% dextrose injection, 500 mg levofloxacin (5 mg/mL) in 100 mL of 5% dextrose (NDC 55150-244-47), from lots CLF160008, CLF160009, CLF160010, and CLF160011 (Exp. 6/18); CLF160015, CLF160016, and CLF160017 (Exp. 8/18); CLF170001 (Exp. 12/18); CLF170023 and CLF170024 (Exp. 5/19); and CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, and CLF170047 (Exp. 8/19).
- levofloxacin in 5% dextrose injection, 750 mg levofloxacin (5 mg/mL) in 150 mL of 5% dextrose (NDC 55150-245-52), from lots CLF160012 and CLF160014 (Exp. 7/18); CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, and CLF170013 (Exp. 2/19); CLF170014, CLF170015, and CLF170016 (Exp. 3/19); CLF170017, CLF170018, and CLF170019 (Exp. 4/19); CLF170020, CLF170021, and CLF170022 (Exp. 5/19); CLF170035, CLF170036, CLF170037, and CLF170038 (Exp. 8/19); and CLF170048, CLF170049, CLF170050, CLF170051, and CLF170052 (Exp. 9/19).
- linezolid injection, 600 mg per 300 mL (2 mg/mL) (NDC 55150-242-51), from lots CLZ160002, CLZ160003, and CLZ160004 (Exp. 7/18); CLZ160005, CLZ160006, CLZ160008, CLZ160009, and CLZ160012 (Exp. 8/18); CLZ160013, CLZ160014, CLZ160015, and CLZ160016 (Exp. 10/18); CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, and CLZ160023 (Exp. 11/18); CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, and CLZ170006 (Exp. 3/19); CLZ170007, CLZ170008, CLZ170009, and CLZ170010 (Exp. 5/19); CLZ170011 and CLZ170012 (Exp. 6/19); CLZ170013, CLZ170014, CLZ170015, and CLZ170016 (Exp. 9/19); and CLZ170017 (Exp. 10/19).
AuroMedics Pharm voluntarily initiated the recall March 27, 2018. The affected injections were distributed across the United States.
Levofloxacin and linezolid are both prescription antibiotics used to treat various types of bacterial infections.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here