Multi event Drug Recall Enforcement Report Class III voluntary initiated by Validus Pharmaceuticals, Inc., originally initiated on 06-15-2018 for the product Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59 The product was recalled due to subpotency: lower than expected potency result was obtained at the 18 month stability time point.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1170-2018 | 06-15-2018 | 09-05-2018 | Class III | 7864 bottles | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Terminated |
| D-1171-2018 | 06-15-2018 | 09-05-2018 | Class III | 696 bottles | 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 | Subpotency: lower than expected potency result was obtained at the 18 month stability time point. | Terminated |
Recalled Products
