The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 86 recalled by Akorn, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 86 products in this recall →

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