Drug product
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
D-1171-2018
Product summary
- Event
- Event 80326
- Status
- Terminated
- Classification
- Class III
- Quantity
- 696 bottles
- Official record key
drug-enforcement:D-1171-2018
Official wording
Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Code information: RV1604, Exp 09/2019
Distribution pattern: U.S. nationwide
Derived failure modes
-
Potency or specification failure
Subpotency