FDA Drug recall D-1427-2014
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41
- FDA Drug
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41 by Boehringer Ingelheim Roxane, citing failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1427-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-01 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Boehringer Ingelheim Roxane |
| Distribution | US |
Product
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Reason
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Identifiers
| ndc | 0054-3120-41 |
|---|---|
| code_info | Lot # 360122A, EXP Date: MAY 2015 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Boehringer Ingelheim Roxane recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1427-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.