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

FDA recall notice · announced September 5, 2018 · Validus Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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 for recall

Subpotency: lower than expected potency result was obtained at the 18 month stability time point.

Notes

Distribution: U.S. nationwide
Lot/code information: RV1604, Exp 09/2019
Quantity: 696 bottles
Status: Terminated
Products in this recall event:
- 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)
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.