Parsippany, NJ, United States
Validus Pharmaceuticals, Inc. recalls
1 recall recorded since 2018, most recently on 15 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Drugs
- Recall started
- 15 June 2018
- Terminated
- 22 January 2021
- Reason
- Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
- Distribution
- U.S. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1171-2018, D-1170-2018
- 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
- Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.