Reported Sep 5, 2018 · Terminated
Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only, Distributed by: Validus Pharmaceuticals, LLC…
Validus Pharmaceuticals, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Validus Pharmaceuticals, Inc. · 119 Cherry Hill Rd Ste 310 · Parsippany, NJ · 07054-1126
Is this the product you have?
- Rocaltrol (calcitriol) Oral Solution, 1 mcg/mL, 15 mL bottle, Rx only
- Distributed byValidus Pharmaceuticals, LLC Parsippany, NJ 07054 USA, NDC 30698-911-15
- Lot codes and dates
RV1604Exp 09/2019
- Amount recalled
- 696 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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