Drug 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
D-1170-2018
Product summary
- Event
- Event 80326
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7864 bottles
- Official record key
drug-enforcement:D-1170-2018
Official wording
Reason: Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Code information: RV1602RB, Exp 07/2019; RV1604RB, Exp 9/2019; RV1605RB, Exp 10/2019
Distribution pattern: U.S. nationwide
Derived failure modes
-
Potency or specification failure
Subpotency