FDAFDA · Food and drugs·Recall number D-1171-2018
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
Published September 5, 2018 · Recall initiated: June 15, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Validus Pharmaceuticals, Inc.
- Distributor
- U.S. nationwide
- Lot
- RV1604, Exp 09/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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