FDA Drug recall D-1171-2018
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 US…
- FDA Drug
- Class III
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class III recall of Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC Parsippany, NJ 07054 US… by Validus Pharmaceuticals, citing subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1171-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-06-15 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Validus Pharmaceuticals |
| Distribution | US |
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
Reason
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Identifiers
| code_info | RV1604, Exp 09/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1171-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.