Class II · Moderate risk
Calcitriol Injection 2 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Calcitriol Oral Solution 1 mcg/mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-3120-41.
Affected NDC
0054-3120-41
Compare with the code on your package — it is the most precise check available.
Drug: Calcitriol
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Calcitriol NDC 00054-3120 |
1 ug/mL | Solution Oral |
Hikma Pharmaceuticals USA Inc. | Rx |
- Recalling firm
- Boehringer Ingelheim Roxane Inc
- NDC code
- 0054-3120-41
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1427-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Calcitriol recalls
See all
Class II · Moderate risk
Calcitriol Injection 1 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk
Rocaltrol (calcitriol)
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Class II · Moderate risk
Calcitriol active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Boehringer Ingelheim Roxane Inc
All 2014 recalls
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class II · Moderate risk
Combivent Respimat
Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.
Class II · Moderate risk
Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack
Subpotent Drug: The firm received an out of specification result for Assay (potency was below specification) at the 9 month stability time point.
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