Calcitriol Oral Solution 1 mcg/mL — Class II drug recall D-1427-2014
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2014-07-16, distributed nationwide. Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month
| Recall number | D-1427-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2014-05-01 |
| Classified | 2014-07-09 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 5,364 bottles |
| Reason classes | specification failure |
| NDC | 00054-3120, 00054-3120-41 |
| Lot numbers | 360122A |
| Expiration dates | 2015-05-20 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1427-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.