Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Calcitriol Oral Solution 1 mcg/mL Recalled by Boehringer Ingelheim Roxane Inc Due to Failed Impurity/Degradation Specification; out of specification for trans-calcitriol...

Date: May 1, 2014
Company: Boehringer Ingelheim Roxane Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boehringer Ingelheim Roxane Inc directly.

Affected Products

Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.

Quantity: 5364 bottles

Why Was This Recalled?

Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boehringer Ingelheim Roxane Inc

Boehringer Ingelheim Roxane Inc has 15 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report