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

FDA recall notice · announced July 16, 2014 · Boehringer Ingelheim Roxane

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: Lot # 360122A, EXP Date: MAY 2015
Quantity: 5364 bottles
Status: Terminated
Products in this recall event:
- Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41. (D-1427-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.