CLASS II Drug recall · Reported 16 Jul 2014 · FDA Enforcement Report
Calcitriol Oral Solution 1 mcg/mL recalled
Boehringer Ingelheim Roxane is recalling Calcitriol Oral Solution 1 mcg/mL, distributed nationwide in the US. The recall was initiated on 1 May 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1427-2014
- FDA event ID
- 68389
- Recalling firm
- Boehringer Ingelheim Roxane, Columbus, OH
- Brand
- Calcitriol
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 May 2014
- FDA classified
- 9 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Vitamins & OTC Supplements
Timeline
| 1 May 2014 | Recall initiated by company | |
| 9 Jul 2014 | Classified by FDA | +69 days |
| 16 Jul 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Where it was distributed
Nationwide
Questions about this recall
Is Calcitriol Oral Solution 1 mcg/mL recalled?
Yes. Boehringer Ingelheim Roxane recalled Calcitriol Oral Solution 1 mcg/mL on 1 May 2014. The recall is Class II and its status is Terminated. Recall number D-1427-2014.
Why was it recalled?
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Which lots are affected?
Lot # 360122A, EXP Date: MAY 2015
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Roxane
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Furosemide Tablets USP, 40 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Furosemide Tablets USP, 20 mg recalled by Boehringer Ingelheim RoxaneFurosemide | Boehringer Ingelheim Roxane | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Combivent Respimat (ipratropium bromide recalledCombivent Respimat | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Acarbose Tablets 50 mg a) Unit Dose Tablets per, b) recalledAcarbose | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride C II Oral Solution USP, 5 mg/ Vial recalled | Boehringer Ingelheim Roxane | Potency & Assay | Nationwide |
Other Calcitriol recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcitriol Injection 2 mcg/mL ampules recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcitriol Injection 1 mcg/mL ampules recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Calcitriol Oral Solution, 1 mcg/mL recalled by Validus Pharmaceuticals | Validus Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcitriol Capsule, 5 mcg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |