Class II · Moderate risk
Calcitriol Injection 2 mcg/mL
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Rocaltrol (calcitriol)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
Affected NDC
30698-0911-15
Compare with the code on your package — it is the most precise check available.
Drug: Calcitriol
- Recalling firm
- Validus Pharmaceuticals, Inc.
- NDC code
- 30698-911-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1171-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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
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.
Class II · Moderate risk
Calcitriol Oral Solution 1 mcg/mL
Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Other recalls by Validus Pharmaceuticals, Inc.
All 2018 recalls
Class III · Low risk
Calcitriol Oral Solution
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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