December 06, 2019
AuroMedics Pharma is recalling numerous lots of amiodarone hydrochloride injection because of crystallization, according to the December 4, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes the following products, which were distributed throughout the United States:
- amiodarone hydrochloride injection, 450 mg/9 mL (50 mg/mL), 9-mL single-dose vial (NDC 55150-181-09) from lots CAH180001 (Exp. 1/20), CAH180003 (Exp. 2/20), and CAH180011 and CAH180012 (Exp. 6/20); and
- amiodarone hydrochloride injection, 900 mg/18 mL (50 mg/mL), 18-mL multiple-dose vial (NDC 55150-182-18) from lots CAH180013 and CAH180014 (Exp. 7/20).
AuroMedics Pharma voluntarily initiated the recall November 11, 2019. The FDA designated it Class III on November 22, 2019. Under the recall classification, use of the affected drug is not likely to cause harm.
Amiodarone hydrochloride injection is a prescription antiarrhythmic used to treat heart rhythm issues.