The Recall Desk
HighFDA (Drugs)·D-0858-2023·Announced 2023-06-07

Calcitriol Injection 2 mcg/mL Recalled Due to CGMP Deviations by Akorn, Inc.

Akorn recalled all lots of Calcitriol Injection 2 mcg/mL nationwide due to CGMP deviations and inability to complete stability studies after the firm went out of business.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies of an injectable drug. Although no illnesses or injuries have been reported, it represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Akorn, Inc. is recalling all lots of Calcitriol Injection 2 mcg/mL, 1 mL ampules (Rx only). The product was distributed nationwide in the USA and Puerto Rico.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. The firm went out of business and could no longer continue the stability studies required to ensure the product's quality and safety.

Patients and healthcare providers should contact their healthcare provider regarding this recall and alternative treatment options. The product should not be dispensed.

The recalled product

Product
Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Manufacturer
Akorn, Inc.
Category
Drug — Injectable
Hazard
  • cgmp-deviation
  • stability-unknown

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category