The Recall Desk
HighFDA (Drugs)·D-0790-2023·Announced 2023-06-07

FDA Recalls Calcitriol Injection Due to Manufacturing Practice Violations

FDA is recalling all lots of Calcitriol Injection 1 mcg/mL due to current good manufacturing practice (CGMP) violations. The manufacturer went out of business and could not complete required stability studies.

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 a prescription injection drug where stability studies could not be completed, representing a risk of harm to patients. However, no illnesses or injuries have been reported, limiting the score to a maximum of 3 per the rubric.

Plain-English summary

Akorn, Inc. is recalling all lots of Calcitriol Injection 1 mcg/mL, 1 mL ampules distributed nationwide in the USA and Puerto Rico. The product is distributed by Akorn Operating Company, LLC., located in Gurnee, Illinois.

The recall was initiated because the manufacturer reported current good manufacturing practice (CGMP) deviations. Specifically, the firm went out of business and could not continue the stability studies that had been required.

Patients currently taking this medication should contact their healthcare provider to discuss their treatment options. Healthcare providers and pharmacists should not dispense remaining stock of the recalled lots.

The recalled product

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

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